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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

December 5, 2008
December 8, 2008
November 2008
March 2009   (final data collection date for primary outcome measure)
HRT Corneal Scan [ Time Frame: baseline and 2 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00804999 on ClinicalTrials.gov Archive Site
Corneal Staining [ Time Frame: baseline and 2 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Normal Contact Lens Wear
  • Drug: Clear Care
    neutralized Clear Care
    Other Name: hydrogen peroxide disinfecting solution
  • Drug: ReNu MultiPlus MPS
    overnight soak in solution
    Other Name: ReNu
  • Drug: OPTI-FREE RepleniSH MPDS
    overnight soak in solution
    Other Name: RepleniSH
  • Placebo Comparator: 1
    neutralized Clear Care and no contact lens wear
    Intervention: Drug: Clear Care
  • Active Comparator: 2
    ReNu with and without sodium fluorescein
    Intervention: Drug: ReNu MultiPlus MPS
  • Active Comparator: 3
    RepleniSH with and without sodium fluorescein
    Interventions:
    • Drug: ReNu MultiPlus MPS
    • Drug: OPTI-FREE RepleniSH MPDS
  • Active Comparator: 4
    ReNu and RepleniSH
    Intervention: Drug: OPTI-FREE RepleniSH MPDS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Not Provided
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Trudy Grout 391-356--7440
United States
 
NCT00804999
M-08-15
No
Christine Sindt/Director, Contact Lens Service, University of Iowa
University of Iowa
Alcon Research
Not Provided
University of Iowa
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP