Dispensing Study for a New Study Lens

Completed · Not applicable

Conditions studied: Myopia

In brief

This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.

Key facts

Study ID

NCT02642991

Run by

CooperVision, Inc.

People needed

44

Starts

2015-11-01

Expected to finish

2016-03-01

Last updated by the study team

2020-12-01

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 (Diopoter) and -4.00D
• Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
• Has not worn lenses for at least 12 hours before the initial visit
• Has a subjective response at baseline, which indicates suitability for this study
• 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
• Any systemic disease affecting ocular health
• Is using any systemic or topical medications that will affect ocular health
• Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
• Has any ocular pathology or anomaly that would affect the wearing of the lenses
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
• Is aphakic
• Has anisometropia of >1.00
• Has undergone corneal refractive surgery
• Has strabismus
• Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity
• Is participating in any other type of eye related clinical or research study
• Has previously participated in study of the Phenacite lenses

Where it is running

• University of California — Berkeley, California, United States
• CORL, Indiana University — Bloomington, Indiana, United States
• Center for Contact Lens Research, University of Waterloo — Waterloo, Ontario, Canada

Full record on ClinicalTrials.gov

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