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

Resource links provided by NLM:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 28, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on October 29, 2014