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

Study Overview
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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.

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

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: narafilcon A contact lens
* Device: nelfilcon A soft contact lenses


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: nelfilcon A OD / narafilcon A OS<br>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<br>* Soft contact lenses with UV protection<br>Device: nelfilcon A soft contact lenses<br>* Soft contact lenses without UV protection<br>|
| Other: narafilcon A OD / nelfilcon A OS<br>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<br>* Soft contact lenses with UV protection<br>Device: nelfilcon A soft contact lenses<br>* Soft contact lenses without UV protection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |