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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 : Completed
First Posted : December 9, 2008
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Christine Sindt, University of Iowa

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 Drug: OPTI-FREE

Detailed Description:

Several types of solutions are used in contact lens wear.

Each contact lens solution used to disinfect contacts have different ingredients even though they all disinfect the contacts.

The objective of this study is to examine the layers of the cornea via HRT in order to assess the usefulness of this technology and to identify any potential consequences of contact lens wear and/or care solution used.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 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
Actual Study Start Date : November 1, 2008
Primary Completion Date : March 1, 2009
Study Completion Date : March 1, 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Placebo Comparator: Placebo 1
Subjects that have never worn contacts with no ocular problems were selected. A baseline HRT was performed. Trial contact lenses were soaked in clear care solution for 10 hours. After 10 hours of the lenses soaking in clear care the subject returned. The contacts lenses that were soaked in clear care were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contact lenses were removed. An HRT was performed immediately after removing the contact lenses. The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
Drug: Clear Care
neutralized Clear Care
Other Name: hydrogen peroxide disinfecting solution
Active Comparator: Renu
Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in ReNu contact solution for 10 hours. After 10 hours of the lenses soaking in ReNu the subject returned. The contacts were inserted onto the patients eyes. The patient then wore the contacts for two hours. After two hours the contacts lenses were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
Drug: ReNu
overnight soak in solution
Active Comparator: Optifree
Subjects that had worn contacts for at least two weeks without incident were selected. A baseline HRT was performed.Trial contacts lenses were soaked in Optifree Replenish contact solution for 10 hours. After 10 hours of the lenses soaking in Optifree Replenish the subject returned. The contacts were inserted onto the patients eyes. The patient wore contacts the for two hours. After two hours the contacts were removed. An HRT both with and without sodium fluorescein was performed immediately after removing the contact lenses.The HRT scans were analyzed for dendritic cell migration, basal cell epithelial density and nerve density and tortuosity.
Drug: OPTI-FREE
overnight soak in solution
Other Name: Replenish



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



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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

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


Locations
United States, Iowa
University of Iowa Contact Lens Clinic
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Christine Sindt
Alcon Research
Investigators
Principal Investigator: Christine W Sindt, O.D. University of Iowa

Publications:

Responsible Party: Christine Sindt, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT00804999     History of Changes
Other Study ID Numbers: 200806729
First Posted: December 9, 2008    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

Keywords provided by Christine Sindt, 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