Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Study Overview
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Brief Summary
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The purpose of this clinical study is to assess 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 with frequent replacement.

Detailed Description
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Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.

Official Title
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Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

Conditions
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Myopia, Refractive Errors, Hyperopia

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Understand and sign an IRB/IEC approved Informed Consent form. Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol. Successful wear of frequent replacement, spherical, daily wear 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. Best spectacle corrected visual acuity 20/20 or better in each eye. Other protocol-defined 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 wear. Any habitual wear of Biofinity lenses. Other protocol-defined exclusion criteria may apply.

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: LID015385<br>LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection. | Device: LID015385 contact lenses<br>* Investigational soft contact lenses<br>Device: CLEAR CARE<br>* Hydrogen peroxide-based cleaning and disinfecting solution<br>|
| Active Comparator: Biofinity<br>Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection. | Device: Comfilcon A contact lenses<br>* Commercially available soft contact lenses<br>* Other names: BIOFINITY®;Device: CLEAR CARE<br>* Hydrogen peroxide-based cleaning and disinfecting solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) | Visual acuity (VA) was assessed for each eye individually with study lenses in place 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. | Week 1 Follow-Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009) | 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, with 20/20 Snellen visual acuity considered normal distance eyesight. | Week 1 Follow-Up, at least 4 hours after lens insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses