A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Subjective Overall Preference
Study Overview
Brief Summary
This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.
The study results were not used for design validation of the investigational product.
Detailed Description
This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A person is eligible for inclusion in the study if they:
- •Are at least 18 years of age and have full legal capacity to volunteer;
- •Have read and signed an information consent letter;
- •Are willing and able to follow instructions and maintain the appointment schedule;
- •Are an adapted soft contact lens wearer;
- •Require spectacle lens powers in both eyes;
- •Sphere: between -1.75 to -6.00 diopters and
- •Astigmatism: between -1.00 to -2.25 and
- •Axis: 180 ± 20 degrees
- •Are willing to wear contact lenses in both eyes;
- •Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
- •To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable.
Exclusion Criteria
- •A person will be excluded from the study if they:
- •Are participating in any concurrent clinical or research study;
- •Have any known active* ocular disease and/or infection;
- •Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- •Are aphakic;
- •Have undergone refractive error surgery;
Outcomes
Primary Outcomes
Subjective Overall Preference
Time Frame: 2 weeks
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Assessment of Visual Quality
Time Frame: 2 weeks
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Subjective Ratings for Comfort
Time Frame: 2 weeks
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Subjective Ratings for Comfort Preference
Time Frame: 2 weeks
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Assessment of Overall Satisfaction
Time Frame: 2 weeks
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Secondary Outcomes
No secondary outcomes reported