A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Coopervision, Inc.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Subjective Response for Vision Satisfaction
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.
Detailed Description
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear. This is a double-masked, randomized, bilateral, two-week crossover, dispensing study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Is no greater than 55 years of age.
- •Has read and understood the information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
- •Has spectacle cylinder ≤1.00D in both eyes.
- •Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- •Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
- •Wears CLs in both eyes (monovision acceptable, but not monofit)
- •Has clear corneas and no active ocular disease.
Exclusion Criteria
- •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 strabismus/amblyopia.
- •Has undergone corneal refractive surgery.
- •Is pregnant, lactating or planning a pregnancy.
Outcomes
Primary Outcomes
Subjective Response for Vision Satisfaction
Time Frame: Baseline - After 10 minutes of lens dispense
Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Response for Overall Vision Satisfaction
Time Frame: 2 Weeks - at night
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Response for Overall Vision Quality
Time Frame: 2 weeks - Night Driving
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Secondary Outcomes
- Subjective Overall Lens Handling(2 weeks)
- Post-blink Movement(2 weeks)
- Lens Horizontal Mobility Rating(2 weeks)
- Corneal Staining Extent(2 weeks)
- Overall Lens Fit Acceptance(2 weeks)
- Lens Handling Satisfaction(2 weeks)
- Subjective Overall Comfort Satisfaction(2 Weeks)
- Subjective Preference for Comfort(2 weeks)
- Lens Surface Wettability Performance(2 weeks)
- Horizontal Lens Centration(2 weeks)
- Vertical Lens Centration(2 weeks)