A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens

Completed

Conditions studied: Myopia

In brief

Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.

Key facts

Study ID

NCT03499067

Run by

CooperVision, Inc.

People needed

58

Starts

2018-04-11

Expected to finish

2018-08-01

Last updated by the study team

2020-08-26

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.
• Requires spectacle lens powers between -0.75 to -6.50 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…

• 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 participating in any other type of eye related clinical or research study.
• Known allergy to a product used in this study (ex. Shellfish allergy)
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

Where it is running

• Clinical Research Center, University of California, Berkeley — Berkeley, 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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