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Compliance and Contamination in Soft Contact Lens Wearers

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.
ClinicalTrials.gov Identifier: NCT01069237
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the lens and lens case microbial colonization associated with marketed care solutions used by experienced soft lens wearers.

Condition or disease Intervention/treatment
Contact Lens Wear Device: OPTI-FREE RepleniSH Device: Clear Care

Detailed Description:
The purpose of this study is to assess the lens and lens case microbial colonization associated marketed care solutions used by experienced soft lens wearers.

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Time Perspective: Prospective
Official Title: Compliance and Contamination in Soft Contact Lens Wearers
Study Start Date : December 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
OPTI-FREE Replenish
Multi-Purpose Solution for soft contact lenses
Device: OPTI-FREE RepleniSH
Multi-Purpose Solution for soft contact lenses
Clear Care
Lens Care Solution for contact lenses
Device: Clear Care
Lens Care Solution for contact lenses


Outcome Measures

Primary Outcome Measures :
  1. Microbial colonization on soft contact lenses and lens cases associated with daily lens wear [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Regimen compliance [ Time Frame: Baseline, 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Contact Lens Wearers
Criteria

Inclusion Criteria:

  • Successful contact lens wear on a daily wear basis
  • Normal Eyes

Exclusion Criteria:

  • Topical ocular medication use
  • No active ocular issues
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): NCT01069237


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami Kern Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01069237     History of Changes
Other Study ID Numbers: SMA-09-45
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
contact lens wear
multi-purpose solution
corneal staining

Additional relevant MeSH terms:
Pharmaceutical Solutions