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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01444313
First received: August 30, 2011
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Refractive Errors
 Device: narafilcon A contact lens
Device: nelfilcon A soft contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Macular Pigment Optical Density at 9 months [ Time Frame: baseline to 9 months ] [ Designated as safety issue: No ]
  • Macular Pigment Optical Density at 15 months [ Time Frame: baseline to 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Macular Pigment Optical Density at 3 months [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
  • Macular Pigment Optical Density at 6 months [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Macular Pigment Optical Density at 12 months [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444313

Locations
United Kingdom
Birmingham, West Midlands, United Kingdom, B4 7ET
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01444313     History of Changes
Other Study ID Numbers: CR-201009
Study First Received: August 30, 2011
Last Updated: January 18, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013