Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Comfilcon A contact lenses; Device: LID014341 contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03586167

CLY935-C004

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

LID014341

Experimental group

Description:

LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis

Treatment:

Device: LID014341 contact lenses

Biofinity

Active Comparator group

Description:

Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis

Treatment:

Device: Comfilcon A contact lenses