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

This study is currently recruiting participants.

Verified by University of Iowa, December 2008

First Received: December 5, 2008 Last Updated: December 8, 2008 History of Changes

Sponsors and Collaborators:	University of Iowa Alcon Research
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00804999

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

MedlinePlus related topics: Eye Wear

Drug Information available for: Hydrogen peroxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Two Phase Clinical Study of the Impact of Contact Lenses and Solutions on Corneal Structure

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
1: Placebo Comparator neutralized Clear Care and no contact lens wear	Drug: Clear Care neutralized Clear Care
2: Active Comparator ReNu with and without sodium fluorescein	Drug: ReNu MultiPlus MPS overnight soak in solution
3: Active Comparator RepleniSH with and without sodium fluorescein	Drug: ReNu MultiPlus MPS overnight soak in solution Drug: OPTI-FREE RepleniSH MPDS overnight soak in solution
4: Active Comparator ReNu and RepleniSH	Drug: OPTI-FREE RepleniSH MPDS overnight soak in solution

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

Keywords provided by University of Iowa:

confocal microscopy
contact lens wear
contact lens solutions
sodium fluorescein

Study placed in the following topic categories:

Anti-Infective Agents, Local
Hydrogen Peroxide
Contact Lens Solutions

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Hydrogen Peroxide
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009