Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Detailed Description
-----------------
Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Official Title
-----------------
Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Device: LID015385 contact lenses
* Device: Comfilcon A soft contact lenses
* Device: CLEAR CARE


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. Manifest cylinder ≤ 0.75 diopter (D) in each eye. Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. Monovision contact lens wearers. Habitually wearing Biofinity® lenses. Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LID015385<br>LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE. | Device: LID015385 contact lenses<br>* Investigational silicone hydrogel contact lenses<br>Device: CLEAR CARE<br>* Hydrogen peroxide-based cleaning and disinfecting system<br>|
| Active Comparator: Biofinity<br>Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE. | Device: Comfilcon A soft contact lenses<br>* Commercially available silicone hydrogel contact lenses<br>* Other names: Biofinity;Device: CLEAR CARE<br>* Hydrogen peroxide-based cleaning and disinfecting system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned. | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit) | 
| Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned. | Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lens, Daily Wear, Vision Correction