A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

Completed · Not applicable

Conditions studied: Myopia, Hyperopia

In brief

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Key facts

Study ID

NCT02345811

Run by

CooperVision, Inc.

People needed

34

Starts

2015-01-01

Expected to finish

2015-03-01

Last updated by the study team

2020-09-16

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
• Has read and signed an information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is an adapted soft contact lens wearer
• Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
• Has no more than 0.75 diopters of refractive astigmatism
• Willing to wear contact lens in both eyes
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
• To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

You may not qualify if…

• Is participating in any concurrent clinical or research study
• Has any known active* ocular disease and/or infection
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
• Is aphakic
• Has undergone refractive error surgery

Where it is running

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

Full record on ClinicalTrials.gov

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