Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Alcon Research1 site in 1 country88 target enrollmentAugust 1, 2018

ConditionsRefractive Errors

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Errors
Sponsor: Alcon Research
Enrollment: 88
Locations: 1
Primary Endpoint: Distance Visual Acuity (VA)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2018

End Date

September 27, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Distance Visual Acuity (VA)

Time Frame: 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.