A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Completed · Not applicable

Conditions studied: Myopia

In brief

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.

Key facts

Study ID

NCT01412983

Run by

Bausch & Lomb Incorporated

People needed

100

Starts

2011-08-01

Expected to finish

2011-10-01

Last updated by the study team

2014-04-29

Who can join

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

You may qualify if…

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
• Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
• Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.

You may not qualify if…

• An active ocular disease, any corneal infiltrative response or are using any ocular medications.
• Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
• Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Any scar or neovascularization within the central 4mm of the cornea.
• Have had any corneal surgery.
• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• Currently wear monovision, multifocal, or toric contact lenses.
• Allergic to any component in the study care products.

Where it is running

• Bausch & Lomb Incorporated — Rochester, New York, United States

Full record on ClinicalTrials.gov

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