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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01444313
First received: August 30, 2011
Last updated: October 28, 2014
Last verified: October 2014

August 30, 2011
October 28, 2014
January 2011
March 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Macular Pigment Ocular 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 ]
Complete list of historical versions of study NCT01444313 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Macular Pigment Ocular Density at 3 months [ Time Frame: baseline to 3 months ] [ Designated as safety issue: No ]
  • Macular Pigment Ocular Density at 6 months [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Macular Pigment Ocular Density at 12 months [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Refractive Errors
  • Device: narafilcon A contact lens
    Soft contact lenses with UV protection
  • Device: nelfilcon A soft contact lenses
    Soft contact lenses without UV protection
  • 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).
    Interventions:
    • Device: narafilcon A contact lens
    • Device: nelfilcon A soft contact lenses
  • 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).
    Interventions:
    • Device: narafilcon A contact lens
    • Device: nelfilcon A soft contact lenses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
March 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01444313
CR-201009
Not Provided
Vistakon
Vistakon
Not Provided
Not Provided
Vistakon
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP