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

Study Overview
=================
Brief Summary
-----------------
This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.

Detailed Description
-----------------
Both test and control lenses will be used in a daily wear modality for 1 month. It is anticipated that this study will involve the following visits: Baseline (screening and dispense visit combined), 2-week visit and 4-week visit.

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

Conditions
-----------------
Myopia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer Has read and understood the information consent letter Is willing and able to follow instructions and maintain the appointment schedule Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction or the assigned study lenses Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.) 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). Rationale is that systemic changes over time due to pregnancy/lactating may adversely affect contact lens wear e.g. ocular dryness may increase. Is aphakic Has undergone corneal refractive 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. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology). ^ For the purposes of this study, participants will be excluded, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

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 in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. | Device: Sapphire Lens<br>* Each subject randomized to wear either the test or control in either the left of right eye.<br>|
| Active Comparator: enfilcon A<br>Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. | Device: enfilcon A<br>* Each subject randomized to wear either the test or control in either the left of right eye.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ratings of Comfort | Subjective ratings of 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 (After 10 minutes of lens dispense) | 
| Subjective Ratings of Comfort | Subjective ratings of 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 | 2 weeks | 
| Subjective Ratings of Comfort | Subjective ratings of 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 | 
| Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | Baseline (after 10 minutes of lens dispense) | 
| Subjective Comfort Preference | Subjective comfort preference Sapphire lens, Enfilcon A, no preference | 2 weeks | 
| Subjective Comfort Preference | Subjective comfort preference Sapphire lens, 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 (After 10 minutes of lens dispense) | 
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | 2 weeks | 
| Lens Wettability | Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced) | 4 weeks |