Evaluation of a New Silicone Hydrogel Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Air Optix Aqua; Device: Test lens

• Registration Number: NCT01309880
• 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: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Results First Submitted: 2014-03-31
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-13
• Last Update Submitted: 2015-02-13
• Results First Posted: 2015-02-23
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria

• Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• An active ocular disease, any corneal infiltrative response or are using any ocular medications.
• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Allergic to any component in the study care products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Air Optix Aqua	Air Optix Aqua	Ciba Vision daily wear contact lens
Test Lens	Test lens	Investigational silicone hydrogel contact lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	Dispensing & 1-week follow up	Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.

Secondary Outcome Measures

Name	Time	Method
Slit Lamp Findings	1 week	Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.
Comfort	1 Weeks	At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.

Trial Locations

Locations (1)

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