Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Study Details
Study Description
Brief Summary
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: comfilcon A toric Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Device: comfilcon A Toric
Contact lenses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Comfort [2 weeks prior to baseline, Baseline, 2 weeks post baseline]
Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
- Overall Vision [2 weeks prior to baseline, Baseline, 2 weeks post]
Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
- Handling [2 weeks prior to baseline, Baseline, 2 weeks post baseline]
Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
- Overall Satisfaction [2 weeks prior to baseline, Baseline, 2 weeks post baseline]
Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
- Lens Fit - Rotation [2 weeks prior to baseline, Baseline, 2 weeks post baseline]
Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
- Lens Fit - Overall Stability [2 weeks prior to baseline, Baseline, 2 weeks post baseline]
Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
- Lens Fit Acceptance [2 weeks prior to baseline, Baseline, 2 weeks post baseline]
General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
- Anterior Ocular Health - Palpebral Hyperemia and Roughness [Baseline and 2 weeks]
Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
- Anterior Ocular Health - Bulbar and Limbal Redness [Baseline and 2 weeks]
Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
- Anterior Ocular Health - Corneal Staining [Baseline and 2 weeks]
Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area
- Anterior Ocular Health - Conjunctival Staining and Indentation [Baseline and 2 weeks]
Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
- Visual Acuity [2 weeks prior to baseline, Baseline, 2 weeks post baseline]
Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
- Subjective Preference - Comfort [Baseline and 2 weeks]
Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
- Preference - Vision [Baseline and 2 weeks]
Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
- Preference - Handling [Baseline and 2 weeks]
Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
- Overall Preference [Baseline and 2 weeks]
Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
- Investigator Acceptability [Baseline and 2 weeks]
Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has had an oculo-visual examination in the last two years
-
Is at least 18 years of age and has full legal capacity to volunteer
-
Has read and understood the information consent letter
-
Is willing and able to follow instructions and maintain the appointment schedule
-
Is correctable to a visual acuity of 20/50 or better (in at least one eye)
-
Currently wears soft toric contact lenses in both eyes
-
Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
-
-20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
-
+8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
-
-20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
-
-6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
-
+6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
-
Has clear corneas and no active ocular disease
-
Demonstrates an acceptable fit with the study lenses
Exclusion Criteria:
-
Has never worn contact lenses before;
-
Has any systemic disease affecting ocular health;
-
Is using any systemic or topical medications that will affect ocular health;
-
Has any ocular pathology or abnormality that would affect the wearing of contact lenses;
-
Has undergone corneal refractive surgery;
-
Is participating in any other type of eye related clinical or research study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | United States | 47405 |
2 | Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston | Houston | Texas | United States | 77204 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Principal Investigator: Jan Bergmanson, OD PhD, Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston
- Principal Investigator: Pete Kollbaum, OD PhD, Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CV-14-05
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Overall Participants |
---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Period Title: Overall Study | |
STARTED | 15 |
COMPLETED | 13 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Overall Baseline Characteristics |
---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Overall Participants | 14 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
14
100%
|
>=65 years |
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
29
(11)
|
Sex: Female, Male (Count of Participants) | |
Female |
11
78.6%
|
Male |
3
21.4%
|
Region of Enrollment (participants) [Number] | |
United States |
14
100%
|
Outcome Measures
Title | Overall Comfort |
---|---|
Description | Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever. |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. |
Arm/Group Title | Habitual Lenses | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 14 | 13 |
Mean (Standard Deviation) [units on a scale] |
80
(16)
|
91
(9)
|
88
(11)
|
Title | Overall Vision |
---|---|
Description | Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time. |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. |
Arm/Group Title | Habitual Lenses | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 14 | 13 |
Mean (Standard Deviation) [units on a scale] |
75
(17)
|
85
(15)
|
80
(18)
|
Title | Handling |
---|---|
Description | Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. |
Arm/Group Title | Habitual Lenses | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 14 | 13 |
Mean (Standard Deviation) [units on a scale] |
88
(25)
|
89
(16)
|
94
(9)
|
Title | Overall Satisfaction |
---|---|
Description | Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied. |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. |
Arm/Group Title | Habitual Lenses | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 14 | 13 |
Mean (Standard Deviation) [units on a scale] |
90
(10)
|
92
(9)
|
89
(10)
|
Title | Lens Fit - Rotation |
---|---|
Description | Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation. |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses. |
Arm/Group Title | Habitual Lenses | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 12 | 14 | 13 |
Measure eyes | 24 | 28 | 26 |
0 degrees |
18
|
29
|
21
|
<=5 degrees |
64
|
71
|
64
|
<=10 degrees |
93
|
86
|
89
|
<=15 degrees |
93
|
93
|
93
|
>15 degrees |
7
|
7
|
7
|
Title | Lens Fit - Overall Stability |
---|---|
Description | Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses. |
Arm/Group Title | Habitual Lenses | Baseline | 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 12 | 14 | 13 |
Measure eyes | 24 | 28 | 26 |
Mean (Standard Deviation) [units on a scale] |
2.8
(0.7)
|
3.3
(0.8)
|
3.3
(0.6)
|
Title | Lens Fit Acceptance |
---|---|
Description | General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum) |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses. |
Arm/Group Title | Habitual Lenses | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 12 | 14 | 13 |
Measure eyes | 24 | 28 | 26 |
Mean (Standard Deviation) [units on a scale] |
3.0
(0.6)
|
3.5
(0.7)
|
3.3
(0.4)
|
Title | Anterior Ocular Health - Palpebral Hyperemia and Roughness |
---|---|
Description | Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
Measure eyes | 28 | 26 |
Palpebral Conjunctival Hyperemia (Superior) |
0.75
(0.81)
|
0.48
(0.33)
|
Palpebral Conjunctival Hyperemia (Inferior) |
0.71
(0.60)
|
0.50
(0.35)
|
Palpebral Conjunctival Papillae (Superior) |
0.61
(0.46)
|
0.58
(0.44)
|
Palpebral Conjunctival Papillae (Inferior) |
0.64
(0.43)
|
0.54
(0.37)
|
Title | Anterior Ocular Health - Bulbar and Limbal Redness |
---|---|
Description | Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
Measure eyes | 28 | 26 |
Bulbar (nasal) |
1.00
(0.71)
|
0.67
(0.45)
|
Bulbar (temporal) |
1.00
(0.75)
|
0.67
(0.45)
|
Bulbar (superior) |
0.79
(0.76)
|
0.63
(0.46)
|
Bulbar (inferior) |
0.79
(0.76)
|
0.62
(0.45)
|
Limbal (nasal) |
0.71
(1.07)
|
0.21
(0.38)
|
Limbal (temporal) |
0.71
(1.07)
|
0.21
(0.38)
|
Limbal (superior) |
0.80
(1.06)
|
0.21
(0.38)
|
Limbal (inferior) |
0.73
(1.09)
|
0.19
(0.35)
|
Title | Anterior Ocular Health - Corneal Staining |
---|---|
Description | Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
Measure eyes | 28 | 26 |
Central |
0.00
(0.00)
|
0.00
(0.00)
|
Nasal |
0.11
(0.31)
|
0.04
(0.20)
|
Temporal |
0.00
(0.00)
|
0.00
(0.00)
|
Superior |
0.04
(0.19)
|
0.04
(0.20)
|
Inferior |
0.11
(0.31)
|
0.12
(0.33)
|
Title | Anterior Ocular Health - Conjunctival Staining and Indentation |
---|---|
Description | Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Conjunctival Staining (Baseline) | Conjunctival Indentation (Baseline) | Conjunctival Staining (2 Weeks) | Conjunctival Indentation (2 Weeks) |
---|---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 14 | 13 | 13 |
Measure eyes | 28 | 28 | 26 | 26 |
Nasal |
0.34
(0.51)
|
0.21
(0.40)
|
0.54
(0.49)
|
0.37
(0.52)
|
Temporal |
0.23
(0.40)
|
0.11
(0.31)
|
0.29
(0.51)
|
0.38
(0.50)
|
Superior |
0.07
(0.18)
|
0.00
(0.00)
|
0.15
(0.31)
|
0.02
(0.10)
|
Inferior |
0.18
(0.43)
|
0.13
(0.35)
|
0.19
(0.38)
|
0.21
(0.38)
|
Title | Visual Acuity |
---|---|
Description | Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR. |
Time Frame | 2 weeks prior to baseline, Baseline, 2 weeks post baseline |
Outcome Measure Data
Analysis Population Description |
---|
One participant discontinued and therefore data was not included in analysis. |
Arm/Group Title | Habitual Lenses | Comfilcon A - Baseline | Comfilcon A - 2 Weeks |
---|---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 14 | 13 |
High Contrast High Illumination (monocular) |
0.06
(0.14)
|
0.06
(0.08)
|
0.07
(0.14)
|
High Contrast High Illumination (binocular) |
-0.04
(0.09)
|
0.00
(0.07)
|
-0.03
(0.09)
|
High Contrast Low Illumination (monocular) |
0.19
(0.13)
|
0.20
(0.09)
|
0.23
(0.13)
|
High Contrast Low Illumination (binocular) |
0.10
(0.09)
|
0.15
(0.10)
|
0.17
(0.14)
|
Title | Subjective Preference - Comfort |
---|---|
Description | Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A- Baseline | Comfilcon A-2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
comfilcon A lenses |
57
|
69
|
No preference |
43
|
23
|
Habitual lenses |
0
|
8
|
Title | Preference - Vision |
---|---|
Description | Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Baseline | Comfilcon A - 2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
comfilcon A XR lenses |
50.0
|
46.2
|
No preference |
28.6
|
15.4
|
Habitual lenses |
21.4
|
38.5
|
Title | Preference - Handling |
---|---|
Description | Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Missing data for handling preference for one participant. |
Arm/Group Title | Comfilcon A- Baseline | Comfilcon A - 2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
comfilcon A lenses |
21.4
|
31
|
No preference |
64.3
|
54
|
Habitual lenses |
7.1
|
15
|
Missing |
7.1
|
0
|
Title | Overall Preference |
---|---|
Description | Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Baseline | Comfilcon A - 2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
comfilcon A lenses |
50
|
46
|
No preference |
43
|
23
|
Habitual lenses |
7
|
31
|
Title | Investigator Acceptability |
---|---|
Description | Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree. |
Time Frame | Baseline and 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Comfilcon A Baseline | Comfilcon A 2 Weeks |
---|---|---|
Arm/Group Description | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. | Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. |
Measure Participants | 14 | 13 |
Agree |
86
|
85
|
Neither Agree nor Disagree |
14
|
15
|
Disagree |
0
|
0
|
Adverse Events
Time Frame | From dispense up to two weeks for each study lenses | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Comfilcon A Toric XR MTO | |
Arm/Group Description | Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses. comfilcon A Toric XR (MTO) contact lenses | |
All Cause Mortality |
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Comfilcon A Toric XR MTO | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
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Comfilcon A Toric XR MTO | ||
Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | |
Other (Not Including Serious) Adverse Events |
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Comfilcon A Toric XR MTO | ||
Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Principal Investigators are NOT employed by the organization sponsoring the study. There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
Results Point of Contact
Name/Title | Sr. Manager, Clinical Research |
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Organization | CooperVision, Inc. |
Phone | 9257306754 |
pchamberlain@coopervision.com |
- CV-14-05