Safety and Efficacy of a Contact Lens for Daily Disposable Use

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Official Title
-----------------
A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use

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

Intervention / Treatment
-----------------
* Device: Test, daily disposable contact lens
* Device: SofLens daily disposable contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye. Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye. Subjects must be free of any anterior segment disorders. Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months. Exclusion Criteria: Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Subjects who have had any corneal surgery (eg, refractive surgery). Subjects who are allergic to any component in the study care products.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test lens<br>Test contact lens will be worn on a daily disposable wear basis. | Device: Test, daily disposable contact lens<br>* Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.<br>|
| Active Comparator: SofLens lens<br>The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. | Device: SofLens daily disposable contact lens<br>* Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings > Grade 2 | Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses | 4 visits over 3 months | 
| High Contrast, Distance logMAR Visual Acuity (VA) | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint | 4 visits over 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lens