A One-Week Crossover Dispensing 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 1 week compared to nelfilcon A (control).

Key facts

Study ID

NCT03306641

Run by

CooperVision, Inc.

People needed

45

Starts

2017-07-28

Expected to finish

2017-08-31

Last updated by the study team

2020-09-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is at least 18 years of age and has full legal capacity to volunteer.
• Is no greater than 55 years of age.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
• 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.
• Wears CLs in both eyes (monvision acceptable, but not monofit)
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination.
• Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

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 strabismus/amblyopia.
• Has undergone corneal refractive surgery.
• Is pregnant, lactating or planning a pregnancy.
• Is participating in any concurrent 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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