A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

Completed · Not applicable

Conditions studied: Myopia

In brief

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Key facts

Study ID

NCT03235089

Run by

CooperVision, Inc.

People needed

31

Starts

2017-07-25

Expected to finish

2017-08-03

Last updated by the study team

2020-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is at least 18 years of age and has full legal capacity to volunteer
• Has read, fully understood and signed the information consent letter
• Currently wears or has previously worn soft contact lenses
• Has spectacle cylinder ≤1.00D in both eyes.
• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
• Has clear corneas and no active ocular disease
• Is willing and able to follow product usage instructions and maintain the visit schedule.

You may not qualify if…

• Has never worn contact lenses before
• 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 any known active ocular disease and/or infection
• Has a monovision correction
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
• Is aphakic
• Has undergone corneal refractive surgery
• Is pregnant or lactating, determined by self-report

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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