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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

December 5, 2008
December 9, 2008
March 31, 2017
January 23, 2018
January 23, 2018
November 1, 2008
March 1, 2009   (Final data collection date for primary outcome measure)
HRT Corneal Scan [ Time Frame: baseline and 2 hours ]
Looking for cell density
HRT Corneal Scan [ Time Frame: baseline and 2 hours ]
Complete list of historical versions of study NCT00804999 on ClinicalTrials.gov Archive Site
Not Provided
Corneal Staining [ Time Frame: baseline and 2 hours ]
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
    overnight soak in solution
  • Drug: OPTI-FREE
    overnight soak in solution
    Other Name: Replenish
  • 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.
    Intervention: Drug: Clear Care
  • 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.
    Intervention: Drug: ReNu
  • 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.
    Intervention: Drug: OPTI-FREE

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
75
March 1, 2009
March 1, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00804999
200806729
No
Not Provided
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.
Christine Sindt, University of Iowa
Christine Sindt
Alcon Research
Principal Investigator: Christine W Sindt, O.D. University of Iowa
University of Iowa
December 2017

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