Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens

NCT ID: NCT01192542

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31

Brief Summary

The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

galyfilcon A prototype lens/enfilcon A lens

galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.

Group Type: OTHER

galyfilcon A prototype lens

Intervention Type: DEVICE

Prototype silicone hydrogel contact lens

enfilcon A lens

Intervention Type: DEVICE

Marketed silicone hydrogel contact lens

enfilcon A lens/galyfilcon A prototype lens

enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.

Group Type: OTHER

galyfilcon A prototype lens

Intervention Type: DEVICE

Prototype silicone hydrogel contact lens

enfilcon A lens

Intervention Type: DEVICE

Marketed silicone hydrogel contact lens

Interventions

galyfilcon A prototype lens

Prototype silicone hydrogel contact lens

Intervention Type: DEVICE

enfilcon A lens

Marketed silicone hydrogel contact lens

Intervention Type: DEVICE

Other Intervention Names

Avaira® contact lens

Eligibility Criteria

Inclusion Criteria

• The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
• 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

Pismo Beach, California, United States

Warwick, Rhode Island, United States

Fincastle, Virginia, United States

Countries

United States

Other Identifiers

CR-1636BE

Identifier Type: -

Identifier Source: org_study_id