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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Refractive Ametropia

Treatments: Device: etafilcon A control lens (EADE); Device: etafilcon A with print and PVP for dark eyes (EAPVPDE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484054

CR-005128

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

EAPVPDE/EADE

Other group

Description:

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.

Treatment:

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

Device: etafilcon A control lens (EADE)

EADE/EAPVPDE

Other group

Description:

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.

Treatment:

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

Device: etafilcon A control lens (EADE)