Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01494818
First received: December 15, 2011
Last updated: July 30, 2013
Last verified: July 2013
Results First Received: July 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Supportive Care
Condition: Contact Lens Care
Interventions: Device: Hydrogen peroxide-based contact lens care system
Device: PHMB-containing contact lens solution
Device: Soft contact lenses

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from one study center located in the United Kingdom.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 79 participants enrolled in the study, 1 participant exited the study between enrollment and product dispensing due to nonavailability. This reporting group includes all enrolled and dispensed participants.

Reporting Groups
  Description
CLEAR CARE/AOSEPT Plus Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
ReNu MultiPlus PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months

Participant Flow:   Overall Study
    CLEAR CARE/AOSEPT Plus     ReNu MultiPlus  
STARTED     39     39  
COMPLETED     37     37  
NOT COMPLETED     2     2  
Relocation                 1                 2  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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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.
This reporting group includes all enrolled and dispensed participants who completed the study.

Reporting Groups
  Description
CLEAR CARE/AOSEPT Plus Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
ReNu MultiPlus PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
Total Total of all reporting groups

Baseline Measures
    CLEAR CARE/AOSEPT Plus     ReNu MultiPlus     Total  
Number of Participants  
[units: participants]
  37     37     74  
Age  
[units: years]
Mean ± Standard Deviation
  34.8  ± 9.8     35.5  ± 10.5     35.1  ± 10.1  
Gender  
[units: participants]
     
Female     21     25     46  
Male     16     12     28  



  Outcome Measures
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1.  Primary:   Maximum Papillae   [ Time Frame: Baseline, Month 3 ]

2.  Primary:   Maximum Eyelid Hyperaemia   [ Time Frame: Baseline, Month 3 ]

3.  Primary:   Upper Lid Redness   [ Time Frame: Baseline, Month 3 ]

4.  Primary:   Change From Baseline in Upper Eyelid Margin Staining at Month 3   [ Time Frame: Baseline, Month 3 ]

5.  Secondary:   Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)   [ Time Frame: Baseline, Month 3 ]

6.  Secondary:   Protective Index   [ Time Frame: Baseline, Month 3 ]

7.  Secondary:   Median Front Lens Deposits   [ Time Frame: Baseline, Month 3 ]

8.  Secondary:   Total Lipid Uptake Per Lens   [ Time Frame: Baseline, Month 3 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Renee Garofalo, OD, FAAO
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01494818     History of Changes
Other Study ID Numbers: ID 10-59 / M-11-02
Study First Received: December 15, 2011
Results First Received: July 30, 2013
Last Updated: July 30, 2013
Health Authority: United Kingdom: Research Ethics Committee