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

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: narafilcon A contact lens; Device: nelfilcon A soft contact lenses

• Registration Number: NCT01444313
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-30
• Primary Completion: 2013-03
• Status Verified: 2014-10
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nelfilcon A OD / narafilcon A OS	nelfilcon A soft contact lenses	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).
narafilcon A OD / nelfilcon A OS	nelfilcon A soft contact lenses	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).
nelfilcon A OD / narafilcon A OS	narafilcon A contact lens	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).
narafilcon A OD / nelfilcon A OS	narafilcon A contact lens	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).

Primary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density at 9 months	baseline to 9 months
Macular Pigment Optical Density at 15 months	baseline to 15 months

Secondary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density at 12 months	baseline to 12 months
Macular Pigment Optical Density at 3 months	baseline to 3 months
Macular Pigment Optical Density at 6 months	baseline to 6 months