Status:
COMPLETED
Clinical Evaluation of Stenfilcon A Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).
Detailed Description
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.
Eligibility Criteria
Inclusion
- A person is eligible for inclusion in the study if he/she:
- Is Japanese
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the informed consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
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 :
March 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03471832
Start Date
March 3 2018
End Date
April 25 2018
Last Update
January 29 2020
Active Locations (4)
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1
Shioya Eye Clinic
Fukushima, Fukushima, Japan, 960-8034
2
Kodama Eye Clinic
Terada, Kyoto, Japan, 610-0121
3
Itoi Eye Clinic
Shibuya City, Tokyo, Japan, 15-0043
4
Ueda Eye Clinic
Shimonoseki, Yamaguchi, Japan, 751-0872