Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Launched by COOPERVISION, INC. · Aug 7, 2019

Keywords

ClinConnect Summary

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.

Gender

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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:
• • 1. No amblyopia
• • 2. No strabismus
• • 3. No evidence of lid abnormality or infection
• • 4. No conjunctival abnormality or infection that would contraindicate contact lens wear
• • 5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
• • 6. No other active ocular disease.
• • Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
• • Willing to comply with the wear and study visit schedule.
• Exclusion Criteria:
• • Using CooperVision Avaira Vitality, J\&J Acuvue 2 or CooperVision Biomedics 55.
• • 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.
• • Abnormal lacrimal secretions.
• • Has diabetes.
• • Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
• • History of chronic eye disease (e.g. glaucoma).
• • Pregnant or lactating or planning a pregnancy at the time of enrolment.
• • Participation in any concurrent clinical trial or in last 30 days.