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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Normal Contact Lens Wear
Interventions: Drug: Clear Care
Drug: ReNu
Drug: OPTI-FREE

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Non Contact Wearer Using Clear Care

neutralized Clear Care and no contact lens wear

Clear Care: neutralized Clear Care

Overnight Soaking With Renu

ReNu with and without sodium fluorescein

ReNu MultiPlus MPS: overnight soak in solution

Overnight Soak in Optifree

RepleniSH with and without sodium fluorescein

ReNu MultiPlus MPS: overnight soak in solution

OPTI-FREE RepleniSH MPDS: overnight soak in solution

Overnight Soak in Optifree Replnish

ReNu and RepleniSH

OPTI-FREE RepleniSH MPDS: overnight soak in solution


Participant Flow:   Overall Study
    Non Contact Wearer Using Clear Care   Overnight Soaking With Renu   Overnight Soak in Optifree   Overnight Soak in Optifree Replnish
STARTED   15   12   14   10 
COMPLETED   15   12   14   10 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Non Contact Lens Wearers Using Clear Care

neutralized Clear Care and no contact lens wear

Clear Care: neutralized Clear Care

Overnight Soaking With Renu

ReNu with and without sodium fluorescein

ReNu MultiPlus MPS: overnight soak in solution

Overnight Soaking in Optifree

RepleniSH with and without sodium fluorescein

ReNu MultiPlus MPS: overnight soak in solution

OPTI-FREE RepleniSH MPDS: overnight soak in solution

Overnight Soaking in Optifree Replinish

ReNu and RepleniSH

OPTI-FREE RepleniSH MPDS: overnight soak in solution

Total Total of all reporting groups

Baseline Measures
   Non Contact Lens Wearers Using Clear Care   Overnight Soaking With Renu   Overnight Soaking in Optifree   Overnight Soaking in Optifree Replinish   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   12   14   10   51 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15 100.0%      12 100.0%      14 100.0%      10 100.0%      51 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      13  86.7%      11  91.7%      13  92.9%      9  90.0%      46  90.2% 
Male      2  13.3%      1   8.3%      1   7.1%      1  10.0%      5   9.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   15   12   14   10   51 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Christine W. Sindt
Organization: University of Iowa
phone: 319-356-2916
e-mail: christine-sindt@uiowa.edu


Publications:


Responsible Party: Christine Sindt, University of Iowa
ClinicalTrials.gov Identifier: NCT00804999     History of Changes
Other Study ID Numbers: 200806729
First Submitted: December 5, 2008
First Posted: December 9, 2008
Results First Submitted: March 31, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018