Status:
COMPLETED
BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine if patients are unreactive to the lens care solution / Biofinity combination.
Detailed Description
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
Eligibility Criteria
Inclusion
- Is over 18 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is currently an adapted spherical soft CL wearer
- Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
- Has less than 1.00D spectacle cylinder in each eye.
- Is correctable to a visual acuity of 20/20 or better in both eyes
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Is willing to comply with the wear schedule (at least 40 hrs per week)
- Is willing to comply with the visit schedule
Exclusion
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
- Has a CL prescription outside the range of - 0.25 to -12.00D
- Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
- Has best corrected spectacle distance vision worse than 20/20 in either eye.
- 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
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars.
- Is aphakic.
- Is pregnant or lactating.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02196766
Start Date
July 1 2014
End Date
August 1 2014
Last Update
July 29 2020
Active Locations (3)
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1
Kokama Eye Clinic
Joyo-shi, Kyoto, Japan, 610-0121
2
Higashihara Clinic
Kameoka, Kyoto, Japan, 621-0861
3
Dougenzaka Ioti Eye Clinic
Shibuya-ku, Tokyo-to, Japan, 150-0043