Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

Johnson & Johnson (J&J)

Status: Completed

Conditions: Refractive Ametropia

Treatments: Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for dark eyes (EADE); Device: etafilcon A with print and PVP for light eyes (EALE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484028

CR-005094

Details and patient eligibility

About

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

Enrollment: 275 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy, female adult, at least 18 years of age, and no more than 34 years of age
• The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
• Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
• Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
• Any cylinder power must be: <=0.75D
• Visual acuity must be best correctable to 20/25 or better for each eye
• Must have normal eyes (no ocular medications or ocular infection of any type)
• Must read and sign the Statement of Informed Consent
• 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 (colorblindness) - 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 must not be 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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275 participants in 4 patient groups

EALE/1DM

Other group

Description:

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

Treatment:

Device: etafilcon A with print and PVP for light eyes (EALE)

Device: etafilcon A control lens (1DM)

1DM/EALE

Other group

Description:

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

Treatment:

Device: etafilcon A with print and PVP for light eyes (EALE)

Device: etafilcon A control lens (1DM)

EADE/1DM

Other group

Description:

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

Treatment:

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

Device: etafilcon A control lens (1DM)

1DM/EADE

Other group

Description:

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

Treatment:

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

Device: etafilcon A control lens (1DM)