A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

Completed · Not applicable

Conditions studied: Myopia

In brief

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Key facts

Study ID

NCT03951610

Run by

CooperVision, Inc.

People needed

52

Starts

2019-02-21

Expected to finish

2019-06-04

Last updated by the study team

2020-06-18

Who can join

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

You may qualify if…

• Has had a self-reported oculo-visual examination in the last two years.
• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
• Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
• Has no more than 0.75 diopters of refractive astigmatism.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

You may not qualify if…

• Is presently participating in any other clinical or research study including eye related clinical or research study.
• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
• Has any known sensitivity to fluorescein dye or products to be used in the study.
• 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 undergone corneal refractive surgery.
• Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).

Where it is running

• University Eye Center at Ketchum Health — Anaheim, California, United States
• Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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