Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Not Applicable

Completed

Interventions: Device: LID014341 contact lenses
Device: Comfilcon A contact lenses

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
LID014341	LID014341 contact lenses	LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis
Biofinity	Comfilcon A contact lenses	Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA)	Day 30	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.

Secondary Outcome Measures