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Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00804999
First received: December 5, 2008
Last updated: December 8, 2008
Last verified: December 2008
History of Changes
  Purpose

Assess the usefulness of using confocal microscopy to examine changes to the structure of the cornea and to identify any potential consequences of contact lens wear and/or solution use.


Condition Intervention
Normal Contact Lens Wear
 Drug: Clear Care
Drug: ReNu MultiPlus MPS
Drug: OPTI-FREE RepleniSH MPDS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure

Resource links provided by NLM:

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

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • HRT Corneal Scan [ Time Frame: baseline and 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal Staining [ Time Frame: baseline and 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2008
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
neutralized Clear Care and no contact lens wear
 Drug: Clear Care
neutralized Clear Care
Other Name: hydrogen peroxide disinfecting solution
Active Comparator: 2
ReNu with and without sodium fluorescein
 Drug: ReNu MultiPlus MPS
overnight soak in solution
Other Name: ReNu
Active Comparator: 3
RepleniSH with and without sodium fluorescein
 Drug: ReNu MultiPlus MPS
overnight soak in solution
Other Name: ReNu
Drug: OPTI-FREE RepleniSH MPDS
overnight soak in solution
Other Name: RepleniSH
Active Comparator: 4
ReNu and RepleniSH
 Drug: OPTI-FREE RepleniSH MPDS
overnight soak in solution
Other Name: RepleniSH

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Vision correctable to 20/30 or better in both eyes
  • Successful soft contact lens wear for at least 2 weeks prior to enrollment

Exclusion Criteria:

  • History of hypersensitivity to any of the components in any of the lens solutions
  • One functional eye or a monofit lens
  • Any abnormal slit-lamp finding at baseline
  • Use of topical ocular meds
  • Any systemic condition with significant ocular side effects or that interfere with contact lens wear
  • Enrollment of the investigator's office staff, relatives or members of their respective households
  • Enrollment of more than one member of the same household
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804999

Contacts
Contact: Trudy Grout 391-356--7440

Locations
United States, Iowa
University of Iowa Contact Lens Clinic Recruiting
Iowa City, Iowa, United States, 52242
Contact: Trudy Grout     319-356-7440        
Principal Investigator: Christine Sindt, OD            
Sponsors and Collaborators
University of Iowa
Alcon Research
  More Information

No publications provided

Responsible Party: Christine Sindt/Director, Contact Lens Service, University of Iowa
ClinicalTrials.gov Identifier: NCT00804999     History of Changes
Other Study ID Numbers: M-08-15
Study First Received: December 5, 2008
Last Updated: December 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
confocal microscopy
contact lens wear
contact lens solutions
sodium fluorescein

Additional relevant MeSH terms:
Hydrogen Peroxide
Contact Lens Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on May 22, 2013