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

NCT ID: NCT01444313

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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

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Conditions

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Refractive Errors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type OTHER

narafilcon A contact lens

Intervention Type DEVICE

Soft contact lenses with UV protection

nelfilcon A soft contact lenses

Intervention Type DEVICE

Soft contact lenses without UV protection

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).

Group Type OTHER

narafilcon A contact lens

Intervention Type DEVICE

Soft contact lenses with UV protection

nelfilcon A soft contact lenses

Intervention Type DEVICE

Soft contact lenses without UV protection

Interventions

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narafilcon A contact lens

Soft contact lenses with UV protection

Intervention Type DEVICE

nelfilcon A soft contact lenses

Soft contact lenses without UV protection

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CR-201009

Identifier Type: -

Identifier Source: org_study_id

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