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
  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:


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
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, see Learn About Clinical Studies.

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 August 26, 2014