Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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):
Alcon Research

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.

Layout table for study information
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
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
Layout table for investigator information
Study Director: Jami Kern Alcon Research

Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01069237    
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:
Layout table for MeSH terms
Pharmaceutical Solutions