Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

Completed · Not applicable

Conditions studied: Myopia

In brief

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Key facts

Study ID

NCT03024970

Run by

CooperVision, Inc.

People needed

72

Starts

2017-01-01

Expected to finish

2017-06-26

Last updated by the study team

2020-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A person is eligible for inclusion in the study if he/she:
• 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.
• Must achieve 20/30 or better (in each eye) with study lenses
• Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
• Has no more than 0.75 diopters of refractive astigmatism.
• Currently wears soft contact lenses.
• Have clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination

You may not qualify if…

• A person will be excluded from the study if he/she:
• 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 undergone corneal refractive surgery.
• Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
• Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Where it is running

• Clinical Optical Research Lab (CORL) — Bloomington, Indiana, United States
• The Ocular Surface Institute (TOSI) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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