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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00724269
First received: July 25, 2008
Last updated: September 28, 2012
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Contact Lens Wear
 Device: OPTI-FREE RepleniSH
Device: ReNu MultiPlus MPS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Screening

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:
  • Confocal microscopy analysis of Corneal Epithelium [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient comfort [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Corneal Staining [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Opti Free RepliniSH
Opti Free RepliniSH
 Device: OPTI-FREE RepleniSH
Multi-Purpose Solution for soft contact lenses
Other Name: OPTI-FREE RepleniSH
Active Comparator: ReNu Multi-Plus
ReNu Multi-Plus
 Device: ReNu MultiPlus MPS
Multi-Purpose Solution for soft contact lenses
Other Name: ReNu MultiPlus MPS

  Eligibility

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00724269     History of Changes
Other Study ID Numbers: SMA-08-04 / BP-08-01
Study First Received: July 25, 2008
Last Updated: September 28, 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 22, 2013