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

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

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: narafilcon A contact lens; Device: nelfilcon A soft contact lenses

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 7ET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: nelfilcon A OD / narafilcon A OS; 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).	Device: narafilcon A contact lens; Soft contact lenses with UV protection; Device: nelfilcon A soft contact lenses; Soft contact lenses without UV protection
Other: narafilcon A OD / nelfilcon A OS; 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).	Device: narafilcon A contact lens; Soft contact lenses with UV protection; Device: nelfilcon A soft contact lenses; Soft contact lenses without UV protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Macular Pigment Optical Density at 3 months	baseline to 3 months
Macular Pigment Optical Density at 6 months	baseline to 6 months
Macular Pigment Optical Density at 12 months	baseline to 12 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-201009