Feasibility of a New Silicone Hydrogel Lens

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

The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Investigational contact lens; Device: Acuvue Oasys Contact Lens; Device: Air Optix Aqua

• Study Type: Interventional
• Enrollment (Actual): 120
• 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:

• Participants must have clear central corneas and be free of any anterior segment disorders.
• Participants must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
• Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion Criteria:

• Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• Participants with any systemic disease affecting ocular health.
• Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Participants with an active ocular disease or are using any ocular medication.
• Participants who have had any corneal surgery (eg, refractive surgery).
• Participants who are allergic to any component in the study care products.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Investigational contact lens; Bausch & Lomb	Device: Investigational contact lens; After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
ACTIVE_COMPARATOR: Acuvue Oasys Contact Lens; Johnson & Johnson Lens	Device: Acuvue Oasys Contact Lens; After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
ACTIVE_COMPARATOR: Air Optix Aqua; Ciba Vision	Device: Air Optix Aqua; After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.	7 days
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Wettability, Test Lens vs. Acuvue Oasys	Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).	7 days
Lens Wettability, Test Lens vs. Air Optix Aqua	Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).	7 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Gerard Carains, MCOptom, PhD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (ESTIMATE): May 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 30, 2014
• Last Update Submitted That Met QC Criteria: March 28, 2014
• Last Verified: March 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: 655