Evaluation of a New Silicone Hydrogel Contact Lens

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Air Optix Aqua; Device: Test lens

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb, Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Air Optix Aqua; Ciba Vision daily wear contact lens	Device: Air Optix Aqua; Air Optix Aqua contact lens worn on a daily wear basis
Experimental: Test Lens; Investigational silicone hydrogel contact lens	Device: Test lens; Investigational silicone hydrogel contact lens worn on a daily wear basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	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.	Dispensing & 1-week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings	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.	1 week
Comfort	At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.	1 Weeks

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Beverly Barna, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 4, 2011
• First Submitted That Met QC Criteria: March 4, 2011
• First Posted (Estimate): March 7, 2011

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 13, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 686E