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Compliance and Contamination in Soft Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01069237
First received: February 15, 2010
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Contact Lens Wear
 Device: OPTI-FREE RepleniSH
Device: Clear Care

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Compliance and Contamination in Soft Contact Lens Wearers

Resource links provided by NLM:

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

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Microbial colonization on soft contact lenses and lens cases associated with daily lens wear [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regimen compliance [ Time Frame: Baseline, 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069237

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01069237     History of Changes
Other Study ID Numbers: SMA-09-45
Study First Received: February 15, 2010
Last Updated: January 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013