NCT04050618
Completed
Not Applicable
Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
ConditionsMyopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Coopervision, Inc.
- Enrollment
- 114
- Locations
- 6
- Primary Endpoint
- Subjective Overall Comfort Rating
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.
Detailed Description
This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be a currently adapted soft contact lens wearer (\>1 month of lens wear).
- •Be at least 18 years of age.
- •Refractive astigmatism \<1.00D in both eyes.
- •Have clear corneas and be free of any anterior segment disorders.
- •Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
- •Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
- •Require visual correction in both eyes (monovision allowed, no monofit).
- •Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia
- •No strabismus
Exclusion Criteria
- •Using CooperVision Avaira Vitality, J\&J Acuvue 2 or CooperVision Biomedics
- •Require toric or multifocal contact lenses.
- •Previously shown a sensitivity to any of the study solution components.
- •Any systemic or ocular disease or allergies affecting ocular health.
- •Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
- •Clinically significant (\>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
- •Keratoconus or other corneal irregularity.
- •Aphakia or amblyopia.
- •Have undergone corneal refractive surgery or any anterior segment surgery.
Outcomes
Primary Outcomes
Subjective Overall Comfort Rating
Time Frame: Four weeks
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Secondary Outcomes
- Average Wearing Time(Four weeks)
- Average Comfortable Wearing Time(Four weeks)
- Lens Centration(Four weeks)
- Corneal Coverage(Four weeks)
- Post-Blink Movement(Four weeks)
- Lens Tightness - Push-up Test(Four weeks)
- Overall Lens Fit Acceptance(Four weeks)
- Rating of Lens Surface Wettability(Four weeks)
- Presence of Film Deposits(Four weeks)
- Number of White Spot Deposits(Four weeks)
- Primary Gaze Lag(Four weeks)
- Comfort Throughout the Day(Day 26 - 8:00pm)
Study Sites (6)
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