A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

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.

Official Title
-----------------
A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

Conditions
-----------------
Myopia, Hyperopia

Intervention / Treatment
-----------------
* Device: Sapphire
* Device: senofilcon A


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sapphire<br>Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. | Device: Sapphire<br>* silicone-hydrogel contact lens<br>|
| Active Comparator: senofilcon A<br>Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. | Device: senofilcon A<br>* contact lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | Baseline (10 minutes post lens settling at dispense) | 
| Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | 2 weeks - During the Day | 
| Vision Quality | Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision) | 2 weeks - End of Day | 
| Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Baseline - 10 minutes post lens settling | 
| Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | 2-weeks - During the Day | 
| Subjective Rating for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | 2-weeks - End of Day | 
| Lens Surface Wettability | Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent) | Baseline (10 minutes post lens settling) | 
| Lens Surface Wettability | Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent) | 2 weeks | 
| Surface Deposits | 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) | Baseline (10 minutes post lens settling) | 
| Surface Deposits | 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) | 2-weeks | 
| Lens Handling (Ease of Insertion) | 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. | 2 weeks | 
| Lens Handling (Ease of Removal) | 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. | 2 weeks | 
| Subjective Preference for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | Baseline - 10 minutes post lens settling | 
| Subjective Preference for Comfort. | Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever | 2 weeks |