A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Sapphire contact lenses
* Device: senofilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sapphire contact lenses<br>Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair. | Device: Sapphire contact lenses<br>* Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair<br>|
| Active Comparator: senofilcon A<br>Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair. | Device: senofilcon A contact lenses<br>* Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | Baseline (10 minutes post lens settling) | 
| Subjective Ratings for Comfort | Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever) | 2 weeks | 
| Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | Baseline (10 minutes post lens settling) | 
| Subjective Ratings for Comfort Preference | Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference | 2 weeks | 
| Subjective Assessment of Visual Quality | 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) | Baseline (10 minutes post lens settling) | 
| Subjective Assessment of Visual Quality | 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) | 2 weeks | 
| Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) | Baseline (10 minutes post lens settling) | 
| Subjective Assessment of Overall Satisfaction | Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied) | 2 weeks | 
| Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | Baseline (10 minutes post lens settling) | 
| Subjective Overall Preference | Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference | 2 weeks |