Status:
COMPLETED
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
Detailed Description
Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and cont...
Eligibility Criteria
Inclusion
- Is between 18 and 40 years of age (inclusive).
- Has had a self-reported visual exam in the last two years.
- Is an adapted wearer of spherical soft contact lenses.
- Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).
- Has a spectacle cylinder up to 0.75 diopter (D) in each eye
- Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
- Has clear corneas and no active ocular disease.
- Has read, understood and signed the information consent letter.
- Is willing to wear his/hers spectacles over the study contact lenses.
- Is willing to comply with the wear schedule.
- 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 contact lens wear (5 days per week; \> 8 hours/day)
- Has a contact lens prescription outside the range of - 1.00 to -10.00D.
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- Does not have a pair of corrective spectacles at the time of the visit.
- Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
- Presence of clinically significant (grade \> 2.0, scale 0-4) anterior segment abnormalities.
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization \> 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT02299869
Start Date
October 1 2014
End Date
November 1 2014
Last Update
March 10 2017
Active Locations (1)
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1
Optometry Clinic, National Autonomous University
Mexico City, Mexico