One Week Assessment of The Phenacite Lens

Completed · Not applicable

Conditions studied: Myopia

In brief

This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance. The study test lens was not the final optical design and the study results were not used for the design validation.

Key facts

Study ID

NCT02553395

Run by

CooperVision, Inc.

People needed

30

Starts

2015-09-01

Expected to finish

2015-10-01

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A person is eligible for inclusion in the study if he/she:
• Oculo-visual examination in the last two years
• Between 18 and 35 years of age and has full legal capacity to volunteer
• Has read and understood the informed consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
• Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.50D
• Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
• Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
• Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.

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 participating in any other type of eye related clinical or research study.

Where it is running

• 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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