A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses

Coopervision, Inc.1 site in 1 country45 target enrollmentJuly 28, 2017

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 45
Locations: 1
Primary Endpoint: Lens Fit Acceptance
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

Detailed Description

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Registry

clinicaltrials.gov

Start Date

July 28, 2017

End Date

August 31, 2017

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is at least 18 years of age and has full legal capacity to volunteer.
•Is no greater than 55 years of age.
•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 lenses for a minimum of 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 20/25 in each eye.
•Wears CLs in both eyes (monvision 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 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 strabismus/amblyopia.
•Has undergone corneal refractive surgery.
•Is pregnant, lactating or planning a pregnancy.