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

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT01412983
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2014-03
• Results First Submitted: 2014-03-27
• Results First Submitted QC: 2014-03-27
• Last Update Submitted: 2014-03-27
• Results First Posted: 2014-04-29
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Visual Acuity	One week	The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.

Secondary Outcome Measures

Name	Time	Method
Overall Comfort	One week	The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States