A Study to Evaluate a New Silicone Hydrogel Contact Lens

Not Applicable

Completed

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

• Registration Number: NCT01309893
• 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.

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
• Status Verified: 2014-11
• Results First Submitted: 2014-11-04
• Results First Submitted QC: 2014-11-20
• Last Update Submitted: 2014-11-20
• Results First Posted: 2014-11-24
• Last Update Posted: 2014-11-24

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 from -0.50 D to -5.50 D in each eye.

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	Air Optix Aqua lens	Bausch \& Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.
Air Optix Aqua Lens	Investigational Lens	Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.
Investigational Lens	Investigational Lens	Bausch \& Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.
Air Optix Aqua Lens	Air Optix Aqua lens	Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.

Primary Outcome Measures

Name	Time	Method
Distance High Contrast logMAR Visual Acuity at 1 Week	Baseline & 1 week	Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week

Secondary Outcome Measures

Name	Time	Method
Overall Comfort	1 week	Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.
Slit Lamp Findings ≥ Grade 2	1 week	Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.

Trial Locations

Locations (1)

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