Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Refractive Errors

Treatments: Device: narafilcon A contact lens; Device: nelfilcon A soft contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01444313

CR-201009

Details and patient eligibility

About

The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject is an adapted soft contact lens wearer
• The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye
• The subject must have a refractive astigmatism in each eye of -0.75D or less
• The subject must have a best corrected visual acuity of 6/9 or better in each eye.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
• The subject must read and sign the statement of informed consent
• The subject must be at least 18 years of age

Exclusion criteria

• Systemic or ocular allergies which might interfere with contact lens wear
• Systemic disease which might interfere with contact lens wear
• Ocular disease which might interfere with contact lens wear
• Grade 3 or 4 Slit Lamp Findings
• Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit
• On changing stable medication or taking any medication known to affect tear film
• Active ocular surface pathology
• Use ocular medication
• Had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study
• Significant ocular tissue anomaly
• Presence of two or more corneal scars in either eye
• Pregnancy or lactation, or intends to become pregnant during the time period of the study
• Any medical condition that may be prejudicial to the study
• Diabetes
• Infectious diseases (e.g. Hepatitis, tuberculosis)
• Contagious immunosuppressive diseases (e.g. HIV)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

nelfilcon A OD / narafilcon A OS

Other group

Description:

Soft contact lens without UV protection worn on the right eye (OD) and soft contact lens with UV protection worn on the left eye (OS).

Treatment:

Device: nelfilcon A soft contact lenses

Device: narafilcon A contact lens

narafilcon A OD / nelfilcon A OS

Other group

Description:

Soft contact lens with UV protection worn on the right eye (OD) and soft contact lens without UV protection worn on the left eye (OS).

Treatment:

Device: nelfilcon A soft contact lenses

Device: narafilcon A contact lens