Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens

NCT ID: NCT01094730

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-01
• Study Completion Date: 2010-04-01

Brief Summary

The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

galyfilcon A prototype/marketed galyfilcon A

The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.

Group Type: OTHER

galyfilcon A prototype lens

Intervention Type: DEVICE

Experimental silicone hydrogel contact lens

marketed galyfilcon A lens

Intervention Type: DEVICE

Marketed silicone hydrogel contact lens.

marketed galyfilcon A/galyfilcon A prototype

The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.

Group Type: OTHER

galyfilcon A prototype lens

Intervention Type: DEVICE

Experimental silicone hydrogel contact lens

marketed galyfilcon A lens

Intervention Type: DEVICE

Marketed silicone hydrogel contact lens.

Interventions

galyfilcon A prototype lens

Experimental silicone hydrogel contact lens

Intervention Type: DEVICE

marketed galyfilcon A lens

Marketed silicone hydrogel contact lens.

Intervention Type: DEVICE

Other Intervention Names

ACUVUE(R) ADVANCE(TM)

Eligibility Criteria

Inclusion Criteria

• The subject must be at least 18 years of age and no more than 39 years of age.
• The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
• Any cylinder power must be ≤ -0.75D.
• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
• The subject must read and sign the Statement of Informed Consent.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

• Ocular or systemic allergies or disease which might interfere with contact lens wear.
• Systemic disease or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Pregnancy or lactation.
• Diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Habitual contact lens type is toric, multifocal, or is worn as extended wear.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cupertino, California, United States

Huntington Beach, California, United States

Los Angeles, California, United States

Pismo Beach, California, United States

Jacksonville, Florida, United States

Orlando, Florida, United States

East Lansing, Michigan, United States

Columbus, Ohio, United States

Amarillo, Texas, United States

Countries

United States

Other Identifiers

CR-1636AY

Identifier Type: -

Identifier Source: org_study_id