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Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium

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: NCT00724269
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.

Condition or disease Intervention/treatment
Contact Lens Wear Device: OPTI-FREE RepleniSH Device: ReNu MultiPlus MPS

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Study Start Date : October 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Opti Free RepliniSH
Opti Free RepliniSH
Device: OPTI-FREE RepleniSH
Multi-Purpose Solution for soft contact lenses
Active Comparator: ReNu Multi-Plus
ReNu Multi-Plus
Device: ReNu MultiPlus MPS
Multi-Purpose Solution for soft contact lenses


Outcome Measures

Primary Outcome Measures :
  1. Confocal microscopy analysis of Corneal Epithelium [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Patient comfort [ Time Frame: 2 weeks ]
  2. Corneal Staining [ Time Frame: 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:   No
Criteria

Inclusion Criteria:

  • Successful contact lens wear on a daily wear basis
  • Wear contact lenses at least 8 hours/day
  • Vision correctable to at least 20/30
  • Normal Eyes
  • Other protocol-defined inclusion criteria may apply

Exclusion:

  • Topical ocular medication use
  • Other protocol-defined inclusion criteria may apply
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): NCT00724269


Locations
United States, Texas
Contact Alcon Call Center for Study Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00724269     History of Changes
Other Study ID Numbers: SMA-08-04 / BP-08-01
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: October 1, 2012
Last Verified: November 2011

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