Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Study Details
Study Description
Brief Summary
The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Lens A daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. |
Device: Lens A
daily disposable soft contact lens - test lens
Device: Lens B
daily disposable soft contact lens - control lens
|
Active Comparator: Lens B daily disposable soft contact lens - control lens Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. |
Device: Lens A
daily disposable soft contact lens - test lens
Device: Lens B
daily disposable soft contact lens - control lens
|
Outcome Measures
Primary Outcome Measures
- Overall Ease of Lens Handling [1 week]
Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)
Secondary Outcome Measures
- Visual Acuity [Baseline - after lenses have settled for 10 minutes]
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
- Visual Acuity [1 week]
Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is at least 18 years of age and has full legal capacity to volunteer;
-
Has read and signed an information consent letter;
-
Self reports having a full eye examination in the previous two years;
-
Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
-
Is willing and able to follow instructions and maintain the appointment schedule;
-
Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
-
Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
-
Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
-
Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
-
Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters
Exclusion Criteria:
-
Is participating in any concurrent clinical or research study;
-
Habitually wears one of the study contact lenses;
-
Has any known active ocular disease and/or infection that contraindicates contact lens wear;
-
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
-
Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
-
Has known sensitivity to the diagnostic sodium fluorescein used in the study;
-
Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
-
Has undergone refractive error surgery or intraocular surgery.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Golden Optometric Group | Whittier | California | United States | 90606 |
2 | Golden Vision | Sarasota | Florida | United States | 34237 |
3 | Sacco Eye Group | Vestal | New York | United States | 13850 |
4 | Athens Eye Care | Athens | Ohio | United States | 45701 |
Sponsors and Collaborators
- Coopervision, Inc.
Investigators
- Study Director: Lyndon Jones, PhD, FCOptom, Centre for Ocular Research and Education
Study Documents (Full-Text)
More Information
Publications
None provided.- EX-MKTG-122
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Lens A, Then Lens B | Lens B, Then Lens A |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens | Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens |
Period Title: First Intervention | ||
STARTED | 24 | 24 |
COMPLETED | 24 | 23 |
NOT COMPLETED | 0 | 1 |
Period Title: First Intervention | ||
STARTED | 24 | 23 |
COMPLETED | 24 | 23 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | daily disposable soft contact lens - test lens Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens Lens B: daily disposable soft contact lens - control lens |
Overall Participants | 48 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
48
100%
|
>=65 years |
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
32.5
(6.8)
|
Sex: Female, Male (Count of Participants) | |
Female |
34
70.8%
|
Male |
14
29.2%
|
Race and Ethnicity Not Collected (Count of Participants) | |
Region of Enrollment (participants) [Number] | |
United States |
48
100%
|
Outcome Measures
Title | Overall Ease of Lens Handling |
---|---|
Description | Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy) |
Time Frame | 1 week |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lens A | Lens B |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens | Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens |
Measure Participants | 47 | 47 |
Mean (Standard Deviation) [units on a scale] |
9.0
(1.1)
|
8.8
(1.5)
|
Title | Visual Acuity |
---|---|
Description | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) |
Time Frame | Baseline - after lenses have settled for 10 minutes |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lens A | Lens B |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens | Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens |
Measure Participants | 47 | 47 |
Mean (Standard Deviation) [logMAR] |
-0.06
(0.06)
|
-0.06
(0.06)
|
Title | Visual Acuity |
---|---|
Description | Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m) |
Time Frame | 1 week |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Lens A | Lens B |
---|---|---|
Arm/Group Description | Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens | Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens |
Measure Participants | 47 | 47 |
Mean (Standard Deviation) [logMAR] |
-0.06
(0.06)
|
-0.05
(0.06)
|
Adverse Events
Time Frame | From dispense up to 1 week on each study lenses for a total of 2 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Lens A | Lens B | ||
Arm/Group Description | Subjects will be randomized to wear test lenses for one week and then cross-over to control lenses for one week. Lens A: daily disposable soft contact lens - test lens | Subjects will be randomized to wear control lenses for one week and then cross-over to test lenses for one week. Lens B: daily disposable soft contact lens - control lens | ||
All Cause Mortality |
||||
Lens A | Lens B | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/48 (0%) | 0/48 (0%) | ||
Serious Adverse Events |
||||
Lens A | Lens B | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/48 (0%) | 0/48 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Lens A | Lens B | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/48 (0%) | 1/48 (2.1%) | ||
Eye disorders | ||||
inferior single corneal peripheral ulcer | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jose A. Vega, O.D., MSc, FAAO |
---|---|
Organization | Coopervision |
Phone | 9256213761 |
JVega2@coopervision.com |
- EX-MKTG-122