Status:
COMPLETED
A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-55 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 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 ...
Eligibility Criteria
Inclusion
- 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.
- Has not worn lenses for at least 12 hours before the examination.
- Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
Exclusion
- 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.
- Is participating in any concurrent clinical or research study.
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03306641
Start Date
July 28 2017
End Date
August 31 2017
Last Update
September 22 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