Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses

Coopervision, Inc.1 site in 1 country35 target enrollmentJune 17, 2021

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 35
Locations: 1
Primary Endpoint: Overall Comfort With Lens
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.

Detailed Description

This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.

Registry

clinicaltrials.gov

Start Date

June 17, 2021

End Date

July 31, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Has had a self-reported oculo-visual examination in the last two years.
•Is at least 18 years of age and has full legal capacity to volunteer.
•Has read and understood the information consent letter.
•Is willing and able to follow instructions and maintain the appointment schedule.
•Is an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study
•Has spectacle cylinder ≤1.00D in both eyes.
•Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
•Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
•Wears CLs in both eyes (monovision acceptable, but not monofit)
•Has clear corneas and no active ocular disease.

Exclusion Criteria

•Has never worn contact lenses before.
•Has any systemic disease affecting ocular health.
•Is using any concomitant systemic or topical medications that will affect ocular health.
•Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
•Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
•Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
•Is aphakic.
•Has undergone corneal refractive surgery.
•Is participating in any other type of eye-related clinical or research study.