Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

Bausch + Lomb

Status: Completed

Conditions: Dry Eye

Treatments: Device: AMO Blink Contacts Lubricant Eye Drops; Device: Lubricating and Rewetting Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01267656

684E

Details and patient eligibility

About

The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
• Use a lens care system on a regular basis.
• Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
• Willing to use drops 4 times per day.

Exclusion criteria

• Participating in a conflicting study.
• An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
• Any scar or neovascularization within the central 4mm of the cornea.
• Any grade 2 or greater finding during the slit lamp examination
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• Aphakic.
• Amblyopic.
• Allergic to any component in the study care products.
• Have had any corneal surgery.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Lubricating and Rewetting Drops

Experimental group

Description:

Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.

Treatment:

Device: Lubricating and Rewetting Drops

AMO Blink Contacts Lubricant Eye Drops

Active Comparator group

Description:

AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week

Treatment:

Device: AMO Blink Contacts Lubricant Eye Drops