Status:
COMPLETED
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Presbyopia
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
Detailed Description
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investiga...
Eligibility Criteria
Inclusion
- Has had a self-reported oculo-visual examination in the last two years.
- Is between ages 40-75 years, inclusive 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 able to participate in Parts A and B related to this work.
- Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
- Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
- Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination.
Exclusion
- A person will be excluded from the study if he/she:
- 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 undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03417557
Start Date
January 12 2018
End Date
April 3 2018
Last Update
May 4 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