Status:
COMPLETED
Comparison of New Contact Lens With Current Marketed Lens
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The purpose of this study is to validate the clinical performance of a new contact lens design.
Detailed Description
Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).
Eligibility Criteria
Inclusion
- Inclusion criteria
- A person is eligible for inclusion in the study if he/she:
- Between and 18 and 35 years of age and has full legal capacity to volunteer
- Has had a self-reported oculo-visual examination in the last two years
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Has a Contact Lens Refraction between -1.00D and -6.00D
- Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
- Currently wears soft contact lenses
- Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
- Has clear corneas and no active ocular disease
- Has not worn lenses for at least 12 hours before the first visit
- Exclusion Criteria
- A person will be excluded from the study if he/she:
- Has never worn contact lenses before
- Is wearing Monovision modality
- 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 undergone corneal refractive surgery
- Is participating in any other type of eye related clinical or research study
Exclusion
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2017
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03360110
Start Date
November 6 2017
End Date
December 15 2017
Last Update
September 2 2020
Active Locations (1)
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1
Clinical Optical Research Lab (CORL)
Bloomington, Indiana, United States, 47405