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

NCT01444053 | Completed FDA Device

• 1 other identifier: CR-201010
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (2)

• Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear

  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.

  Approximately 40 minutes

• Amplitude of Accommodation after 5 years of contact lens wear

  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.

  Approximately 40 minutes

Study Arms (2)

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

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

Interventions

No Intervention DEVICE

No Intervention

Wearers of contact lenses with UV Protection; Wearers of contact lenses without UV Protection

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 30, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

GB (1)