A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens

Study Overview
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Brief Summary
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This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear. The study results were not used for design validation of test lens.

Detailed Description
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Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month. The study results were not used for design validation of test lens.

Official Title
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A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Sapphire Lens
* Device: enfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will only be eligible for the study if: Is at least 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 -6.50 diopters sphere; 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: Subjects will not be eligible to take part in the study if: 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; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sapphire lens<br>Each subject will be randomized to wear the test lens on one eye and control lens on one eye. | Device: Sapphire Lens<br>* Each subject will be randomized to wear the test lens on one eye and control lens on one eye.<br>|
| Active Comparator: enfilcon A<br>Each subject will be randomized to wear the test lens on one eye and control lens on one eye. | Device: enfilcon A<br>* Each subject will be randomized to wear the test lens on one eye and control lens on one eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ratings for Comfort After Lens Insertion | Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever | Baseline (5 minutes post lens dispensing) | 
| Subjective Ratings for Comfort After Lens Insertion | Subjective ratings for comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever | 4 weeks | 
| Percentage of Participants With a Lens Preference Based on Subjective Comfort | Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference | Baseline (5 minutes post lens dispensing) | 
| Percentage of Participants With a Lens Preference Based on Subjective Comfort | Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference | 4 weeks | 
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | Baseline (5 minutes post lens dispensing) | 
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | 4 weeks | 
| Lens Surface Deposition | Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface) | Baseline (5 minutes post lens dispensing) | 
| Lens Surface Deposition | Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface) | 4 weeks |