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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444053
First Posted: September 30, 2011
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
  Purpose
The purpose of this study is to examine the long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.

Condition Intervention
Refractive Errors Device: No Intervention

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear [ Time Frame: Approximately 40 minutes ]
    The MPOD will be assessed at a single visit will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.

  • Amplitude of Accommodation after 5 years of contact lens wear [ Time Frame: Approximately 40 minutes ]
    Measured with autorefractor at a single visit and will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history.


Enrollment: 41
Actual Study Start Date: June 1, 2011
Study Completion Date: December 1, 2011
Primary Completion Date: December 1, 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Wearers of contact lenses without UV Protection
Subjects who have worn a soft contact lens without UV protection for the past five years or more.
Device: No Intervention
No Intervention
Wearers of contact lenses with UV Protection
Subjects who have worn a soft contact lens with UV protection for the last 5 years or more.
Device: No Intervention
No Intervention

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subject selection is based on a history of wearing one of two types of contact lenses for at least five years. Age-matching subjects into 4 age-brackets will be attempted with a target of five subjects in each age bracket among the two types of lenses.
Criteria

Inclusion Criteria:

  • The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens
  • The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week.
  • The subject must have best corrected visual acuity of 6/7.5 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 between 18 and 43 years of age

Exclusion Criteria:

  • On medication known to affect accommodation
  • Active ocular surface pathology
  • Had eye surgery
  • Significant ocular tissue anomaly
  • Any medical condition that may be prejudicial to the study
  • Diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444053


Locations
United Kingdom
Birmingham, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01444053     History of Changes
Other Study ID Numbers: CR-201010
First Submitted: August 30, 2011
First Posted: September 30, 2011
Last Update Posted: June 20, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases