Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Study Overview
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Brief Summary
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The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.

Official Title
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Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: LID014341 contact lenses
* Device: Comfilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign an informed consent form approved by an Institutional review board (IRB); Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; Best-corrected visual acuity (BCVA) 20/25 or better in each eye; Willing to stop wearing habitual contact lenses for the duration of study participation. Exclusion Criteria: Any conditions or use of medications that could contraindicate contact lens wear; History of or plan to have refractive surgery in either eye; Irregular cornea in either eye; Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; Current or history of intolerance, hypersensitivity or allergy to any component of the study products; 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; Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear; Habitual Biofinity contact lens wearers.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LID014341<br>LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis | Device: LID014341 contact lenses<br>* Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating<br>|
| Active Comparator: Biofinity<br>Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis | Device: Comfilcon A contact lenses<br>* Silicone hydrogel contact lenses<br>* Other names: BIOFINITY©;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) | VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned. | Day 30 |