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

Information source: University of Iowa
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Normal Contact Lens Wear

Intervention: Clear Care (Drug); ReNu MultiPlus MPS (Drug); OPTI-FREE RepleniSH MPDS (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Iowa

Overall contact:
Trudy Grout, Phone: 391-356--7440

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: HRT Corneal Scan

Secondary outcome: Corneal Staining

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Trudy Grout, Phone: 391-356--7440

University of Iowa Contact Lens Clinic, Iowa City, Iowa 52242, United States; Recruiting
Trudy Grout, Phone: 319-356-7440
Christine Sindt, OD, Principal Investigator
Additional Information

Starting date: November 2008
Last updated: December 8, 2008

Page last updated: August 20, 2015

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