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

Completed · Not applicable

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT04050618

Run by

CooperVision, Inc.

People needed

114

Starts

2019-06-09

Expected to finish

2019-11-08

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• No evidence of lid abnormality or infection
• No conjunctival abnormality or infection that would contraindicate contact lens wear
• No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
• 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.

You may not qualify if…

• 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.

Where it is running

• Golden Optometric Group — Whittier, California, United States
• Omega Vision Center PA (DBA Sabal Eye Care) — Longwood, Florida, United States
• Golden Vision — Sarasota, Florida, United States
• Sacco Eye Group — Vestal, New York, United States
• Frazier Vision, Inc — Tyler, Texas, United States
• Office of William J. Bogus, O.D. — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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