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

Refractive Errors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444053
• Other study ID #: CR-201010
• Status: Completed
• Phase: N/A
• First received: August 30, 2011
• Last updated: June 16, 2017
• Start date: June 1, 2011
• Est. completion date: December 1, 2011

Study information

• Verified date: June 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 1, 2011
• Est. primary completion date: December 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• No Intervention
No Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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