Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

NCT ID: NCT01484054

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-02-29

Brief Summary

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Conditions

Refractive Ametropia

Study Design

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

Study Groups

EAPVPDE/EADE

etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.

Group Type: OTHER

etafilcon A with print and PVP for dark eyes (EAPVPDE)

Intervention Type: DEVICE

A daily disposable contact lens

etafilcon A control lens (EADE)

Intervention Type: DEVICE

A marketed daily disposable contact lens

EADE/EAPVPDE

etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.

Group Type: OTHER

etafilcon A with print and PVP for dark eyes (EAPVPDE)

Intervention Type: DEVICE

A daily disposable contact lens

etafilcon A control lens (EADE)

Intervention Type: DEVICE

A marketed daily disposable contact lens

Interventions

etafilcon A with print and PVP for dark eyes (EAPVPDE)

A daily disposable contact lens

Intervention Type: DEVICE

etafilcon A control lens (EADE)

A marketed daily disposable contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
• The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
• The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
• The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
• The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
• The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
• Any cylinder power must be:<=0.75D.
• The subject must have visual acuity best correctable to 20/25 or better for each eye.
• The subject must have normal eyes (no ocular medications or ocular infection of any type).
• 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, autoimmune disease, or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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.
• Any color deficiencies (color blindness) - to the best of the subject's knowledge.
• 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.
• Subject presents with one dark iris color and one light iris color
• Subject has heterochromia iridis (a difference in color between parts of one iris)
• The subject is an employee or family member of the clinical study site.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bloomfield, Connecticut, United States

Tallahassee, Florida, United States

Overland Park, Kansas, United States

Jamestown, New York, United States

Kingston, Pennsylvania, United States

Moon Township, Pennsylvania, United States

Countries

United States

Other Identifiers

CR-005128

Identifier Type: -

Identifier Source: org_study_id