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CompletedNCT01444053Updated Jun 20, 2017

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

An observational study in Refractive Errors, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2017-06-20.

Sponsored by Johnson & Johnson Vision Care, Inc. · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
41
Ages
18 Years to 43 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Refractive Errors

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03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 41 is below the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
41 participants (actual)

Groups and cohorts

  • 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

  • DeviceNo Intervention

    No Intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 40 minutes

  2. 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.

    Time frame: Approximately 40 minutes

07

Study locations

1 site
  • Birmingham, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01444053
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Sep 30, 2011
Start date
Jun 1, 2011
Primary completion
Dec 1, 2011
Completion
Dec 1, 2011
Last update
Jun 20, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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