A Study to Evaluate the Efficacy of Investigational OTC Eye Drops
Study Details
Study Description
Brief Summary
This is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Eligible participants will use assigned eye drop products as directed. Participants will be required to attend 2 consecutive clinic visits. Assessments for eye redness and eye comfort will be completed. Participants will complete brief questionnaires about their eyes.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Formula # 13418-148
|
Drug: F# 13418-148 Eye Drops
ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day
|
Experimental: Formula # 13418-158
|
Drug: F#13418-158 Eye Drops
ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day
|
Active Comparator: Control Formula # PF004390
|
Drug: F# PF-004390 Eye Drops
Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day
|
Outcome Measures
Primary Outcome Measures
- Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application [Baseline to 60 seconds after first product application]
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
- Percentage of Participants With Response to Redness at 60 Seconds After First Product Application [Baseline to 60 seconds after first product application]
The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
Secondary Outcome Measures
- Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application [Baseline to 30 seconds after first product application]
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
- Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application [Baseline to 2 minutes after first product application]
Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
- Clinician Assessment of Baseline Redness [Baseline]
Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.
- Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application [Baseline to 60 seconds after first product application]
Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
- Change From Baseline in Ocular Comfort at 10 Hours After First Product Application [Baseline to 10 hours after first product application]
Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
- Change From Baseline in Ocular Comfort at 12 Hours After First Product Application [Baseline to 12 hours after first product application]
Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.
- My Eye Feels Hydrated - Baseline [Baseline]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Hydrated - 2 Minutes After First Application [2 minutes after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Hydrated - 10 Hours After First Application [10 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Hydrated - 12 Hours After First Application [12 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Refreshed - 2 Minutes After First Application [2 minutes after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Refreshed - 10 Hours After First Application [10 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Refreshed - 12 Hours After First Application [12 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Gives me Confidence to Approach Others - Baseline [Baseline]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application [2 minutes after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application [10 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application [12 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Can Show How I Really Feel - Baseline [Baseline]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application [2 minutes after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application [10 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application [12 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears Healthy - Baseline [Baseline]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears Healthy - 2 Minutes After First Application [2 minutes after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears Healthy - 10 Hours After First Application [10 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears Healthy - 12 Hours After First Application [12 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Cool - 2 Minutes After First Application [2 minutes after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Cool - 10 Hours After First Application [10 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Feels Cool - 12 Hours After First Application [12 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears to Sparkle - Baseline [Baseline]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears to Sparkle - 2 Minutes After First Application [2 minutes after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears to Sparkle - 10 Hours After First Application [10 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
- My Eye Appears to Sparkle - 12 Hours After First Application [12 hours after first application]
Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
-
Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
-
Male or female of any race or ethnicity, aged 18 years and older;
-
Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
-
Able to read and understand English;
-
Healthy subjects with redness in both eyes
-
History of topical ocular drugs or desire to use within the last 6 months;
-
Ocular health within normal limits,
-
Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.
Exclusion Criteria:
-
Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
-
Known sensitivity, allergy or contraindications to any investigational product ingredient;
-
Females who are pregnant, planning to become pregnant or breastfeeding during the study;
-
Subjects who were previously screened and determined to be ineligible for the study;
-
Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
-
Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
-
Relative, partner or staff of any clinical research site personnel;
-
Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
-
Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
-
Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
-
Has a compromised immune system;
-
Has any acute or chronic, medical or psychiatric conditions
-
Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
-
Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
-
Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Andover Eye Associates | Andover | Massachusetts | United States | 01810 |
Sponsors and Collaborators
- Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
- Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates
Study Documents (Full-Text)
More Information
Publications
- Cronau H, Kankanala RR, Mauger T. Diagnosis and management of red eye in primary care. Am Fam Physician. 2010 Jan 15;81(2):137-44. Review.
- Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30. Review.
- Murphy PJ, Lau JS, Sim MM, Woods RL. How red is a white eye? Clinical grading of normal conjunctival hyperaemia. Eye (Lond). 2007 May;21(5):633-8. Epub 2006 Mar 3.
- CO-161103095739-VCCT
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | F#13418-148/F#13418-158 | F#13418-148/F#PF004390 | F#13418-158/F#PF004390 |
---|---|---|---|
Arm/Group Description | Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0% | Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05% | Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05% |
Period Title: Overall Study | |||
STARTED | 41 | 38 | 41 |
COMPLETED | 41 | 38 | 41 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | F#13418-148/F#13418-158 | F#13418-148/F#PF004390 | F#13418-158/F#PF004390 | Total |
---|---|---|---|---|
Arm/Group Description | Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0% | Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05% | Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05% | Total of all reporting groups |
Overall Participants | 41 | 38 | 41 | 120 |
Age (Years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Years] |
55.4
(15.58)
|
59.1
(13.85)
|
54.9
(12.47)
|
56.4
(14.03)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
27
65.9%
|
22
57.9%
|
26
63.4%
|
75
62.5%
|
Male |
14
34.1%
|
16
42.1%
|
15
36.6%
|
45
37.5%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
White |
36
87.8%
|
36
94.7%
|
39
95.1%
|
111
92.5%
|
Black or African-American |
3
7.3%
|
1
2.6%
|
0
0%
|
4
3.3%
|
Asian |
1
2.4%
|
0
0%
|
1
2.4%
|
2
1.7%
|
Other |
1
2.4%
|
1
2.6%
|
1
2.4%
|
3
2.5%
|
Race/Ethnicity, Customized (Count of Participants) | ||||
Hispanic or Latino |
1
2.4%
|
3
7.9%
|
7
17.1%
|
11
9.2%
|
Not Hispanic or Latino |
40
97.6%
|
35
92.1%
|
34
82.9%
|
109
90.8%
|
Region of Enrollment (Count of Participants) | ||||
United States |
41
100%
|
38
100%
|
41
100%
|
120
100%
|
Outcome Measures
Title | Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application |
---|---|
Description | Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
Time Frame | Baseline to 60 seconds after first product application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure eyes | 79 | 79 | 82 |
Mean (Standard Error) [units on a scale] |
0.31
(0.050)
|
0.27
(0.050)
|
0.32
(0.049)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F# 13418-148 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Prespecified equivalence interval of (-0.22, 0.44). | |
Statistical Test of Hypothesis | p-Value | 0.392 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.04 | |
Confidence Interval |
(2-Sided) 95% -0.140 to 0.055 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.049 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F#13418-158 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Prespecified equivalence interval of (-0.22, 0.44) | |
Statistical Test of Hypothesis | p-Value | 0.828 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.01 | |
Confidence Interval |
(2-Sided) 95% -0.086 to 0.107 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.049 |
|
Estimation Comments |
Title | Percentage of Participants With Response to Redness at 60 Seconds After First Product Application |
---|---|
Description | The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
Time Frame | Baseline to 60 seconds after first product application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Number [Percentage] |
53.6
|
50.1
|
50.1
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F# 13418-148 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Prespecified equivalence interval of (0.80, 1.25). | |
Statistical Test of Hypothesis | p-Value | 0.576 |
Comments | ||
Method | GEE model | |
Comments | GEE model with treatment as factor. | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.87 | |
Confidence Interval |
(2-Sided) 95% 0.539 to 1.411 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F#13418-158 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | Prespecified equivalence interval of (0.80, 1.25) | |
Statistical Test of Hypothesis | p-Value | 0.544 |
Comments | ||
Method | GEE model | |
Comments | GEE model with treatment as factor. | |
Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
Estimated Value | 0.87 | |
Confidence Interval |
(2-Sided) 95% 0.552 to 1.368 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application |
---|---|
Description | Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
Time Frame | Baseline to 30 seconds after first product application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure eyes | 79 | 79 | 82 |
Mean (Standard Error) [units on a scale] |
0.10
(0.046)
|
0.09
(0.046)
|
0.11
(0.046)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F# 13418-148 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified for this time point. | |
Statistical Test of Hypothesis | p-Value | 0.893 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.01 | |
Confidence Interval |
(2-Sided) 95% -0.085 to 0.074 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.040 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F#13418-158 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified for this time point. | |
Statistical Test of Hypothesis | p-Value | 0.886 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.01 | |
Confidence Interval |
(2-Sided) 95% -0.073 to 0.084 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.040 |
|
Estimation Comments |
Title | Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application |
---|---|
Description | Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
Time Frame | Baseline to 2 minutes after first product application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure eyes | 79 | 79 | 82 |
Mean (Standard Error) [units on a scale] |
0.88
(0.048)
|
0.80
(0.048)
|
0.83
(0.048)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F# 13418-148 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified for this time point. | |
Statistical Test of Hypothesis | p-Value | 0.117 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.08 | |
Confidence Interval |
(2-Sided) 95% -0.177 to 0.020 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.050 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F#13418-158 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified for this time point. | |
Statistical Test of Hypothesis | p-Value | 0.255 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.06 | |
Confidence Interval |
(2-Sided) 95% -0.153 to 0.041 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.049 |
|
Estimation Comments |
Title | Clinician Assessment of Baseline Redness |
---|---|
Description | Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure eyes | 79 | 79 | 82 |
Mean (Standard Deviation) [units on a scale] |
1.64
(0.537)
|
1.66
(0.497)
|
1.76
(0.498)
|
Title | Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application |
---|---|
Description | Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better. |
Time Frame | Baseline to 60 seconds after first product application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure eyes | 79 | 79 | 82 |
Mean (Standard Error) [units on a scale] |
-1.4
(0.21)
|
-1.1
(0.21)
|
-1.2
(0.20)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F# 13418-148 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified. | |
Statistical Test of Hypothesis | p-Value | 0.085 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -0.05 to 0.78 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F#13418-158 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified for this time point. | |
Statistical Test of Hypothesis | p-Value | 0.269 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -0.18 to 0.64 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
Estimation Comments |
Title | Change From Baseline in Ocular Comfort at 10 Hours After First Product Application |
---|---|
Description | Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better. |
Time Frame | Baseline to 10 hours after first product application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure eyes | 79 | 79 | 82 |
Mean (Standard Error) [units on a scale] |
-1.4
(0.20)
|
-1.7
(0.20)
|
-1.6
(0.20)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F# 13418-148 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified. | |
Statistical Test of Hypothesis | p-Value | 0.162 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -0.60 to 0.10 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F#13418-158 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified for this time point. | |
Statistical Test of Hypothesis | p-Value | 0.234 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -0.55 to 0.14 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
Estimation Comments |
Title | Change From Baseline in Ocular Comfort at 12 Hours After First Product Application |
---|---|
Description | Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better. |
Time Frame | Baseline to 12 hours after first product application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure eyes | 79 | 79 | 82 |
Mean (Standard Error) [units on a scale] |
-1.4
(0.20)
|
-1.5
(0.20)
|
-1.6
(0.20)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F# 13418-148 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified. | |
Statistical Test of Hypothesis | p-Value | 0.398 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -0.48 to 0.19 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | F# PF004390 Eye Drops, F#13418-158 Eye Drops |
---|---|---|
Comments | ||
Type of Statistical Test | Equivalence | |
Comments | No equivalence interval was specified for this time point. | |
Statistical Test of Hypothesis | p-Value | 0.233 |
Comments | ||
Method | ANCOVA | |
Comments | Mixed effect ANCOVA with treatment as factor and baseline value as a covariate. | |
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | -0.2 | |
Confidence Interval |
(2-Sided) 95% -0.54 to 0.13 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
Estimation Comments |
Title | My Eye Feels Hydrated - Baseline |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
8.9
21.7%
|
10.1
26.6%
|
8.5
20.7%
|
Somewhat agree (4) |
30.4
74.1%
|
34.2
90%
|
28.0
68.3%
|
Neither agree or disagree (3) |
10.1
24.6%
|
12.7
33.4%
|
9.8
23.9%
|
Somewhat disagree (2) |
30.4
74.1%
|
30.4
80%
|
34.1
83.2%
|
Strongly disagree (1) |
17.7
43.2%
|
10.1
26.6%
|
19.5
47.6%
|
No opinion |
2.5
6.1%
|
2.5
6.6%
|
0
0%
|
Title | My Eye Feels Hydrated - 2 Minutes After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 2 minutes after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
45.6
111.2%
|
39.2
103.2%
|
43.9
107.1%
|
Somewhat agree (4) |
48.1
117.3%
|
49.4
130%
|
42.7
104.1%
|
Neither agree or disagree (3) |
3.8
9.3%
|
3.8
10%
|
7.3
17.8%
|
Somewhat disagree (2) |
1.3
3.2%
|
6.3
16.6%
|
6.1
14.9%
|
Strongly disagree (1) |
1.3
3.2%
|
1.3
3.4%
|
0
0%
|
No opinion |
0
0%
|
0
0%
|
0
0%
|
Title | My Eye Feels Hydrated - 10 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 10 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
31.6
77.1%
|
43.0
113.2%
|
29.3
71.5%
|
Somewhat agree (4) |
41.8
102%
|
35.4
93.2%
|
41.5
101.2%
|
Neither agree or disagree (3) |
10.1
24.6%
|
8.9
23.4%
|
11.0
26.8%
|
Somewhat disagree (2) |
11.4
27.8%
|
8.9
23.4%
|
13.4
32.7%
|
Strongly disagree (1) |
2.5
6.1%
|
2.5
6.6%
|
4.9
12%
|
No opinion |
1.3
3.2%
|
1.3
3.4%
|
0
0%
|
Title | My Eye Feels Hydrated - 12 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 12 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
36.7
89.5%
|
35.4
93.2%
|
30.5
74.4%
|
Somewhat agree (4) |
43.0
104.9%
|
40.5
106.6%
|
41.5
101.2%
|
Neither agree or disagree (3) |
3.8
9.3%
|
6.3
16.6%
|
7.3
17.8%
|
Somewhat disagree (2) |
12.7
31%
|
8.9
23.4%
|
17.1
41.7%
|
Strongly disagree (1) |
2.5
6.1%
|
6.3
16.6%
|
3.7
9%
|
No opinion |
0
0%
|
0
0%
|
0
0%
|
Title | My Eye Feels Refreshed - 2 Minutes After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 2 minutes after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
38.0
92.7%
|
36.7
96.6%
|
42.7
104.1%
|
Somewhat agree (4) |
46.8
114.1%
|
44.3
116.6%
|
36.6
89.3%
|
Neither agree or disagree (3) |
7.6
18.5%
|
10.1
26.6%
|
14.6
35.6%
|
Somewhat disagree (2) |
6.3
15.4%
|
8.9
23.4%
|
4.9
12%
|
Strongly disagree (1) |
1.3
3.2%
|
0
0%
|
1.2
2.9%
|
No opinion |
0
0%
|
0
0%
|
0
0%
|
Title | My Eye Feels Refreshed - 10 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 10 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
32.9
80.2%
|
34.2
90%
|
32.9
80.2%
|
Somewhat agree (4) |
36.7
89.5%
|
45.6
120%
|
43.9
107.1%
|
Neither agree or disagree (3) |
13.9
33.9%
|
3.8
10%
|
6.1
14.9%
|
Somewhat disagree (2) |
13.9
33.9%
|
15.2
40%
|
9.8
23.9%
|
Strongly disagree (1) |
1.3
3.2%
|
1.3
3.4%
|
7.3
17.8%
|
No opinion |
0
0%
|
0
0%
|
0
0%
|
Title | My Eye Feels Refreshed - 12 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 12 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
27.8
67.8%
|
30.4
80%
|
26.8
65.4%
|
Somewhat agree (4) |
38.0
92.7%
|
36.7
96.6%
|
37.8
92.2%
|
Neither agree or disagree (3) |
16.5
40.2%
|
12.7
33.4%
|
14.6
35.6%
|
Somewhat disagree (2) |
11.4
27.8%
|
12.7
33.4%
|
12.2
29.8%
|
Strongly disagree (1) |
3.8
9.3%
|
5.1
13.4%
|
8.5
20.7%
|
No opinion |
0
0%
|
1.3
3.4%
|
0
0%
|
Title | The Appearance of my Eye Gives me Confidence to Approach Others - Baseline |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
43.0
104.9%
|
30.4
80%
|
30.5
74.4%
|
Somewhat agree (4) |
25.3
61.7%
|
31.6
83.2%
|
26.8
65.4%
|
Neither agree or disagree (3) |
20.3
49.5%
|
20.3
53.4%
|
23.2
56.6%
|
Somewhat disagree (2) |
1.3
3.2%
|
5.1
13.4%
|
8.5
20.7%
|
Strongly disagree (1) |
2.5
6.1%
|
3.8
10%
|
7.3
17.8%
|
No opinion |
7.6
18.5%
|
8.9
23.4%
|
3.7
9%
|
Title | The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 2 minutes after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
46.8
114.1%
|
39.2
103.2%
|
37.8
92.2%
|
Somewhat agree (4) |
24.1
58.8%
|
32.9
86.6%
|
36.6
89.3%
|
Neither agree or disagree (3) |
20.3
49.5%
|
11.4
30%
|
15.9
38.8%
|
Somewhat disagree (2) |
1.3
3.2%
|
3.8
10%
|
2.4
5.9%
|
Strongly disagree (1) |
1.3
3.2%
|
2.5
6.6%
|
4.9
12%
|
No opinion |
6.3
15.4%
|
10.1
26.6%
|
2.4
5.9%
|
Title | The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 10 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
46.8
114.1%
|
51.9
136.6%
|
46.3
112.9%
|
Somewhat agree (4) |
29.1
71%
|
26.6
70%
|
28.0
68.3%
|
Neither agree or disagree (3) |
10.1
24.6%
|
8.9
23.4%
|
14.6
35.6%
|
Somewhat disagree (2) |
6.3
15.4%
|
6.3
16.6%
|
4.9
12%
|
Strongly disagree (1) |
0
0%
|
1.3
3.4%
|
2.4
5.9%
|
No opinion |
6.3
15.4%
|
5.1
13.4%
|
3.7
9%
|
Title | The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 12 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
38.0
92.7%
|
38.0
100%
|
30.5
74.4%
|
Somewhat agree (4) |
36.7
89.5%
|
32.9
86.6%
|
37.8
92.2%
|
Neither agree or disagree (3) |
15.2
37.1%
|
13.9
36.6%
|
18.3
44.6%
|
Somewhat disagree (2) |
1.3
3.2%
|
1.3
3.4%
|
3.7
9%
|
Strongly disagree (1) |
0
0%
|
5.1
13.4%
|
3.7
9%
|
No opinion |
7.6
18.5%
|
7.6
20%
|
6.1
14.9%
|
Title | The Appearance of my Eye Can Show How I Really Feel - Baseline |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
34.2
83.4%
|
29.1
76.6%
|
25.6
62.4%
|
Somewhat agree (4) |
36.7
89.5%
|
40.5
106.6%
|
37.8
92.2%
|
Neither agree or disagree (3) |
15.2
37.1%
|
16.5
43.4%
|
18.3
44.6%
|
Somewhat disagree (2) |
3.8
9.3%
|
2.5
6.6%
|
9.8
23.9%
|
Strongly disagree (1) |
1.3
3.2%
|
3.8
10%
|
3.7
9%
|
No opinion |
8.9
21.7%
|
7.6
20%
|
4.9
12%
|
Title | The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 2 minutes after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
36.7
89.5%
|
34.2
90%
|
35.4
86.3%
|
Somewhat agree (4) |
34.2
83.4%
|
43.0
113.2%
|
40.2
98%
|
Neither agree or disagree (3) |
19.0
46.3%
|
12.7
33.4%
|
14.6
35.6%
|
Somewhat disagree (2) |
3.8
9.3%
|
6.3
16.6%
|
2.4
5.9%
|
Strongly disagree (1) |
1.3
3.2%
|
0
0%
|
2.4
5.9%
|
No opinion |
5.1
12.4%
|
3.8
10%
|
4.9
12%
|
Title | The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 10 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
35.4
86.3%
|
31.6
83.2%
|
32.9
80.2%
|
Somewhat agree (4) |
31.6
77.1%
|
36.7
96.6%
|
31.7
77.3%
|
Neither agree or disagree (3) |
20.3
49.5%
|
22.8
60%
|
24.4
59.5%
|
Somewhat disagree (2) |
2.5
6.1%
|
2.5
6.6%
|
1.2
2.9%
|
Strongly disagree (1) |
0
0%
|
1.3
3.4%
|
2.4
5.9%
|
No opinion |
8.9
21.7%
|
5.1
13.4%
|
7.3
17.8%
|
Title | The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 12 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
34.2
83.4%
|
35.4
93.2%
|
32.9
80.2%
|
Somewhat agree (4) |
38.0
92.7%
|
36.7
96.6%
|
40.2
98%
|
Neither agree or disagree (3) |
17.7
43.2%
|
15.2
40%
|
18.3
44.6%
|
Somewhat disagree (2) |
3.8
9.3%
|
2.5
6.6%
|
3.7
9%
|
Strongly disagree (1) |
0
0%
|
1.3
3.4%
|
1.2
2.9%
|
No opinion |
5.1
12.4%
|
6.3
16.6%
|
3.7
9%
|
Title | My Eye Appears Healthy - Baseline |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
40.5
98.8%
|
41.8
110%
|
45.1
110%
|
Somewhat agree (4) |
35.4
86.3%
|
31.6
83.2%
|
25.6
62.4%
|
Neither agree or disagree (3) |
10.1
24.6%
|
15.2
40%
|
8.5
20.7%
|
Somewhat disagree (2) |
5.1
12.4%
|
6.3
16.6%
|
11.0
26.8%
|
Strongly disagree (1) |
6.3
15.4%
|
3.8
10%
|
7.3
17.8%
|
No opinion |
2.5
6.1%
|
1.3
3.4%
|
2.4
5.9%
|
Title | My Eye Appears Healthy - 2 Minutes After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 2 minutes after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
46.8
114.1%
|
44.3
116.6%
|
42.7
104.1%
|
Somewhat agree (4) |
40.5
98.8%
|
34.2
90%
|
37.8
92.2%
|
Neither agree or disagree (3) |
8.9
21.7%
|
13.9
36.6%
|
13.4
32.7%
|
Somewhat disagree (2) |
1.3
3.2%
|
5.1
13.4%
|
3.7
9%
|
Strongly disagree (1) |
0
0%
|
1.3
3.4%
|
1.2
2.9%
|
No opinion |
2.5
6.1%
|
1.3
3.4%
|
1.2
2.9%
|
Title | My Eye Appears Healthy - 10 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 10 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
48.1
117.3%
|
50.6
133.2%
|
48.8
119%
|
Somewhat agree (4) |
29.1
71%
|
27.8
73.2%
|
28.0
68.3%
|
Neither agree or disagree (3) |
11.4
27.8%
|
12.7
33.4%
|
13.4
32.7%
|
Somewhat disagree (2) |
5.1
12.4%
|
6.3
16.6%
|
6.1
14.9%
|
Strongly disagree (1) |
0
0%
|
0
0%
|
1.2
2.9%
|
No opinion |
5.1
12.4%
|
2.5
6.6%
|
2.4
5.9%
|
Title | My Eye Appears Healthy - 12 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 12 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
54.4
132.7%
|
51.9
136.6%
|
47.6
116.1%
|
Somewhat agree (4) |
29.1
71%
|
22.8
60%
|
28.0
68.3%
|
Neither agree or disagree (3) |
11.4
27.8%
|
11.4
30%
|
18.3
44.6%
|
Somewhat disagree (2) |
1.3
3.2%
|
5.1
13.4%
|
2.4
5.9%
|
Strongly disagree (1) |
0
0%
|
1.3
3.4%
|
0
0%
|
No opinion |
2.5
6.1%
|
5.1
13.4%
|
2.4
5.9%
|
Title | My Eye Feels Cool - 2 Minutes After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 2 minutes after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
29.1
71%
|
20.3
53.4%
|
29.3
71.5%
|
Somewhat agree (4) |
40.5
98.8%
|
44.3
116.6%
|
32.9
80.2%
|
Neither agree or disagree (3) |
24.1
58.8%
|
24.1
63.4%
|
25.6
62.4%
|
Somewhat disagree (2) |
6.3
15.4%
|
7.6
20%
|
8.5
20.7%
|
Strongly disagree (1) |
0
0%
|
2.5
6.6%
|
2.4
5.9%
|
No opinion |
0
0%
|
1.3
3.4%
|
1.2
2.9%
|
Title | My Eye Feels Cool - 10 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 10 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
24.1
58.8%
|
20.3
53.4%
|
13.4
32.7%
|
Somewhat agree (4) |
29.1
71%
|
36.7
96.6%
|
34.1
83.2%
|
Neither agree or disagree (3) |
21.5
52.4%
|
25.3
66.6%
|
23.2
56.6%
|
Somewhat disagree (2) |
17.7
43.2%
|
10.1
26.6%
|
14.6
35.6%
|
Strongly disagree (1) |
2.5
6.1%
|
6.3
16.6%
|
13.4
32.7%
|
No opinion |
2.5
6.1%
|
1.3
3.4%
|
1.2
2.9%
|
Title | My Eye Feels Cool - 12 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 12 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
20.3
49.5%
|
22.8
60%
|
17.1
41.7%
|
Somewhat agree (4) |
29.1
71%
|
27.8
73.2%
|
29.3
71.5%
|
Neither agree or disagree (3) |
31.6
77.1%
|
30.4
80%
|
24.4
59.5%
|
Somewhat disagree (2) |
12.7
31%
|
10.1
26.6%
|
17.1
41.7%
|
Strongly disagree (1) |
5.1
12.4%
|
5.1
13.4%
|
11.0
26.8%
|
No opinion |
0
0%
|
2.5
6.6%
|
1.2
2.9%
|
Title | My Eye Appears to Sparkle - Baseline |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | Baseline |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
3.8
9.3%
|
6.3
16.6%
|
9.8
23.9%
|
Somewhat agree (4) |
24.1
58.8%
|
20.3
53.4%
|
19.5
47.6%
|
Neither agree or disagree (3) |
34.2
83.4%
|
38.0
100%
|
35.4
86.3%
|
Somewhat disagree (2) |
11.4
27.8%
|
8.9
23.4%
|
7.3
17.8%
|
Strongly disagree (1) |
7.6
18.5%
|
11.4
30%
|
13.4
32.7%
|
No opinion |
19.0
46.3%
|
15.2
40%
|
14.6
35.6%
|
Title | My Eye Appears to Sparkle - 2 Minutes After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 2 minutes after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
6.3
15.4%
|
8.9
23.4%
|
14.6
35.6%
|
Somewhat agree (4) |
34.2
83.4%
|
26.6
70%
|
20.7
50.5%
|
Neither agree or disagree (3) |
30.4
74.1%
|
35.4
93.2%
|
37.8
92.2%
|
Somewhat disagree (2) |
5.1
12.4%
|
6.3
16.6%
|
4.9
12%
|
Strongly disagree (1) |
3.8
9.3%
|
7.6
20%
|
8.5
20.7%
|
No opinion |
20.3
49.5%
|
15.2
40%
|
13.4
32.7%
|
Title | My Eye Appears to Sparkle - 10 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 10 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
19.0
46.3%
|
15.2
40%
|
17.1
41.7%
|
Somewhat agree (4) |
29.1
71%
|
34.2
90%
|
28.0
68.3%
|
Neither agree or disagree (3) |
27.8
67.8%
|
31.6
83.2%
|
29.3
71.5%
|
Somewhat disagree (2) |
10.1
24.6%
|
2.5
6.6%
|
7.3
17.8%
|
Strongly disagree (1) |
1.3
3.2%
|
7.6
20%
|
9.8
23.9%
|
No opinion |
11.4
27.8%
|
8.9
23.4%
|
8.5
20.7%
|
Title | My Eye Appears to Sparkle - 12 Hours After First Application |
---|---|
Description | Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed. |
Time Frame | 12 hours after first application |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat set |
Arm/Group Title | F# PF004390 Eye Drops | F# 13418-148 Eye Drops | F#13418-158 Eye Drops |
---|---|---|---|
Arm/Group Description | Active Comparator - Tetrahydrozoline 0.05% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.40% | Experimental - Tetrahydrozoline 0.05%; glycerin 0.20%; hypromellose 0.20%; polyethylene glycol 400 1.0% |
Measure Participants | 79 | 79 | 82 |
Measure Eyes | 79 | 79 | 82 |
Strongly agree (5) |
17.7
43.2%
|
13.9
36.6%
|
19.5
47.6%
|
Somewhat agree (4) |
29.1
71%
|
25.3
66.6%
|
24.4
59.5%
|
Neither agree or disagree (3) |
31.6
77.1%
|
38.0
100%
|
26.8
65.4%
|
Somewhat disagree (2) |
8.9
21.7%
|
5.1
13.4%
|
9.8
23.9%
|
Strongly disagree (1) |
2.5
6.1%
|
7.6
20%
|
11.0
26.8%
|
No opinion |
8.9
21.7%
|
8.9
23.4%
|
8.5
20.7%
|
Adverse Events
Time Frame | Through 24-hour end-of-study visit; + up to 30 days for unresolved adverse events; +30 days for serious adverse events | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | AEs were systematically collected during the study. AEs that were unresolved upon completion or termination from the study were followed for up to 30 calendar days until the event or its sequelae resolved or stabilized. Serious AEs were collected through 30 calendar days after the participant's last study visit. | |||||
Arm/Group Title | F#13418-148/F#13418-158 | F#13418-148/F#PF004390 | F#13418-158/F#PF004390 | |||
Arm/Group Description | Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0% | Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05% | Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05% | |||
All Cause Mortality |
||||||
F#13418-148/F#13418-158 | F#13418-148/F#PF004390 | F#13418-158/F#PF004390 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/41 (0%) | 0/38 (0%) | 0/41 (0%) | |||
Serious Adverse Events |
||||||
F#13418-148/F#13418-158 | F#13418-148/F#PF004390 | F#13418-158/F#PF004390 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/41 (0%) | 0/38 (0%) | 0/41 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
F#13418-148/F#13418-158 | F#13418-148/F#PF004390 | F#13418-158/F#PF004390 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/41 (0%) | 0/38 (0%) | 0/41 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Prior to submission for publication, PI was to provide sponsor with ≥ 60 days for publication review. No publication that included sponsor confidential information was to be submitted without sponsor's prior written consent. If requested, the PI was to withhold publication for up to 60 additional days to allow for patent application filing.
Results Point of Contact
Name/Title | Amisha Parikh-Das, PhD, MPH |
---|---|
Organization | Johnson & Johnson Consumer Inc. |
Phone | (973) 255-8701 |
AParikh1@its.jnj.com |
- CO-161103095739-VCCT