Status:
COMPLETED
A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours 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 6 hours compared to nelfilcon A (control). The primary outcomes of interest ar...
Eligibility Criteria
Inclusion
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read, fully understood and signed the information consent letter
- Currently wears or has previously worn soft contact lenses
- 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.
- Has clear corneas and no active ocular disease
- Is willing and able to follow product usage instructions and maintain the visit schedule.
Exclusion
- Has never worn contact lenses before
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- Has any known active ocular disease and/or infection
- Has a monovision correction
- Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
- Is aphakic
- Has undergone corneal refractive surgery
- Is pregnant or lactating, determined by self-report
Key Trial Info
Start Date :
July 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03235089
Start Date
July 25 2017
End Date
August 3 2017
Last Update
October 14 2020
Active Locations (1)
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1
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States, 47405