A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Vision Quality
Study Overview
Brief Summary
To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.
Detailed Description
This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
- •Has read and signed an information consent letter
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is an adapted soft contact lens wearer
- •Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
- •Has no more than 0.75 diopters of refractive astigmatism
- •Willing to wear contact lens in both eyes
- •Has manifest refraction visual acuities (VA) equal to or better than logMAR 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 as acceptable
Exclusion Criteria
- •Is participating in any concurrent clinical or research study
- •Has any known active* ocular disease and/or infection
- •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 a study outcome variable
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
- •Is aphakic
- •Has undergone refractive error surgery
Arms & Interventions
Sapphire
Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.
Intervention: Sapphire (Device)
senofilcon A
Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.
Intervention: senofilcon A (Device)
Outcomes
Primary Outcomes
Vision Quality
Time Frame: 2 weeks - End of Day
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Surface Deposits
Time Frame: 2-weeks
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)
Lens Handling (Ease of Insertion)
Time Frame: 2 weeks
Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Lens Handling (Ease of Removal)
Time Frame: 2 weeks
Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.
Subjective Rating for Comfort.
Time Frame: 2-weeks - End of Day
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Preference for Comfort.
Time Frame: 2 weeks
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Lens Surface Wettability
Time Frame: 2 weeks
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Vision Quality
Time Frame: Baseline (10 minutes post lens settling at dispense)
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Vision Quality
Time Frame: 2 weeks - During the Day
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Subjective Rating for Comfort.
Time Frame: Baseline - 10 minutes post lens settling
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Rating for Comfort.
Time Frame: 2-weeks - During the Day
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Lens Surface Wettability
Time Frame: Baseline (10 minutes post lens settling)
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Surface Deposits
Time Frame: Baseline (10 minutes post lens settling)
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)
Subjective Preference for Comfort.
Time Frame: Baseline - 10 minutes post lens settling
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Secondary Outcomes
No secondary outcomes reported