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OpenTrials
Completed

NCT Number: NCT01444313

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.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham, West Midlands, B4 7ET, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Narafilcon A contact lens

Device

Soft contact lenses with UV protection

nelfilcon A soft contact lenses

Device

Soft contact lenses without UV protection

Primary outcomes

  1. Macular Pigment Optical Density at 9 months

    Time frame: baseline to 9 months

  2. Macular Pigment Optical Density at 15 months

    Time frame: baseline to 15 months

Secondary outcomes

  1. Macular Pigment Optical Density at 3 months

    Time frame: baseline to 3 months

  2. Macular Pigment Optical Density at 6 months

    Time frame: baseline to 6 months

  3. Macular Pigment Optical Density at 12 months

    Time frame: baseline to 12 months

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
First posted
Sep 30, 2011
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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