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

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ClinicalTrials.gov Identifier: NCT00804999
Recruitment Status : Unknown
Verified December 2008 by University of Iowa.
Recruitment status was:  Recruiting
First Posted : December 9, 2008
Last Update Posted : December 9, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Normal Contact Lens Wear Drug: Clear Care Drug: ReNu MultiPlus MPS Drug: OPTI-FREE RepleniSH MPDS

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure
Study Start Date : November 2008
Estimated Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. HRT Corneal Scan [ Time Frame: baseline and 2 hours ]

Secondary Outcome Measures :
  1. Corneal Staining [ Time Frame: baseline and 2 hours ]

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:   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

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): 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

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
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: December 9, 2008
Last Verified: December 2008

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents