A Study to Evaluate the Efficacy of Investigational OTC Eye Drops

Sponsor
Johnson & Johnson Consumer Inc. (J&JCI) (Industry)
Overall Status
Completed
CT.gov ID
NCT03198000
Collaborator
(none)
120
1
3
23
158.8

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
  • Drug: F# 13418-148 Eye Drops
  • Drug: F#13418-158 Eye Drops
  • Drug: F# PF-004390 Eye Drops
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

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Single-Center, Randomized, Controlled Study to Evaluate the Efficacy of Two Investigational OTC Eye Drops in Healthy Adults With Red Eye
Actual Study Start Date :
Jun 28, 2017
Actual Primary Completion Date :
Jul 21, 2017
Actual Study Completion Date :
Jul 21, 2017

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

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. 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;

  2. Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research

  3. Male or female of any race or ethnicity, aged 18 years and older;

  4. Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);

  5. Able to read and understand English;

  6. Healthy subjects with redness in both eyes

  7. History of topical ocular drugs or desire to use within the last 6 months;

  8. Ocular health within normal limits,

  9. 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:
  1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);

  2. Known sensitivity, allergy or contraindications to any investigational product ingredient;

  3. Females who are pregnant, planning to become pregnant or breastfeeding during the study;

  4. Subjects who were previously screened and determined to be ineligible for the study;

  5. 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;

  6. Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);

  7. Relative, partner or staff of any clinical research site personnel;

  8. 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;

  9. Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;

  10. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;

  11. Has a compromised immune system;

  12. Has any acute or chronic, medical or psychiatric conditions

  13. Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;

  14. Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;

  15. 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

Responsible Party:
Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier:
NCT03198000
Other Study ID Numbers:
  • CO-161103095739-VCCT
First Posted:
Jun 23, 2017
Last Update Posted:
Sep 18, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Johnson & Johnson Consumer Inc. (J&JCI)
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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
3. Secondary Outcome
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
4. Secondary Outcome
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
5. Secondary Outcome
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)
6. Secondary Outcome
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
7. Secondary Outcome
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
8. Secondary Outcome
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
9. Secondary Outcome
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%
10. Secondary Outcome
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%
11. Secondary Outcome
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%
12. Secondary Outcome
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%
13. Secondary Outcome
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%
14. Secondary Outcome
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%
15. Secondary Outcome
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%
16. Secondary Outcome
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%
17. Secondary Outcome
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%
18. Secondary Outcome
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%
19. Secondary Outcome
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%
20. Secondary Outcome
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%
21. Secondary Outcome
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%
22. Secondary Outcome
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%
23. Secondary Outcome
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%
24. Secondary Outcome
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%
25. Secondary Outcome
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%
26. Secondary Outcome
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%
27. Secondary Outcome
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%
28. Secondary Outcome
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%
29. Secondary Outcome
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%
30. Secondary Outcome
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%
31. Secondary Outcome
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%
32. Secondary Outcome
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%
33. Secondary Outcome
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%
34. Secondary Outcome
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

[Not Specified]

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
Email AParikh1@its.jnj.com
Responsible Party:
Johnson & Johnson Consumer Inc. (J&JCI)
ClinicalTrials.gov Identifier:
NCT03198000
Other Study ID Numbers:
  • CO-161103095739-VCCT
First Posted:
Jun 23, 2017
Last Update Posted:
Sep 18, 2018
Last Verified:
Aug 1, 2018