Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens

Not Applicable

Completed

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

• Registration Number: NCT01309906
• 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 an investigational contact lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

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

Inclusion Criteria

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
• Be myopic and require lens correction in each eye.
• 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

• 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
Investigational lens	Investigational lens	Bausch \& Lomb investigational silicone hydrogel lens
Air Optix Aqua lens	Air Optix Aqua lens	Ciba Vision Air Optix Aqua contact lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	At 1 week follow up	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary Outcome Measures

Name	Time	Method
Symptoms and Complaints	At 1 week follow up	At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score.
Percentage of Eyes With > Grade 2 Slit Lamp Findings	At 1 week follow up	Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.

Trial Locations

Locations (1)

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