Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis

Completed · Not applicable

Conditions studied: Myopia

In brief

The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.

Key facts

Study ID

NCT02939950

Run by

Bausch Health Americas, Inc.

People needed

816

Starts

2015-04-30

Expected to finish

2016-08-03

Last updated by the study team

2019-12-23

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
• Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
• Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
• Participants must have clear central corneas and be free of any anterior segment disorders.
• Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.

You may not qualify if…

• Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• Participants with an active ocular disease or who are using any ocular medication.
• Participants with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
• Participants who currently wear monovision, multifocal, or toric contact lenses.

Where it is running

• Cicero Family Eye Care — Cicero, New York, United States

Full record on ClinicalTrials.gov

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