A Study to Evaluate 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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Investigational Lens; Device: Air Optix Aqua 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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
Experimental: Investigational Lens; Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.	Device: Investigational Lens; Lenses worn on a daily wear basis for one week; Device: Air Optix Aqua lens; Lenses worn on a daily wear basis for one week
Active Comparator: Air Optix Aqua Lens; Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.	Device: Investigational Lens; Lenses worn on a daily wear basis for one week; Device: Air Optix Aqua lens; Lenses worn on a daily wear basis for one week

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings ≥ Grade 2	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.	1 week
Overall Comfort	Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.	1 week

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Robert Steffen, OD, MS, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 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): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 687E