An Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues (ID11-56)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01594294
First received: May 7, 2012
Last updated: June 27, 2014
Last verified: June 2014
Results First Received: June 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Supportive Care
Condition: Myopia
Interventions: Device: AOSEPT® Plus contact lens solution
Device: ReNu MultiPlus® contact lens solution
Device: Etafilcon A contact lenses
Device: Lotrafilcon B contact lenses
Device: COMPLETE® MPS Easy Rub® Formula contact lens solution

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 100 participants enrolled, 21 were exited as screen failures prior to initiation of the Investigational Phase. This reporting group includes all participants randomized into the Investigational Phase (79).

Reporting Groups
  Description
AOSEPT Plus AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
ReNu MultiPlus ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)

Participant Flow:   Overall Study
    AOSEPT Plus     ReNu MultiPlus  
STARTED     39     40  
COMPLETED     36     36  
NOT COMPLETED     3     4  



  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 analysis population includes all participants who completed the study as per the protocol.

Reporting Groups
  Description
AOSEPT Plus AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
ReNu MultiPlus ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
Total Total of all reporting groups

Baseline Measures
    AOSEPT Plus     ReNu MultiPlus     Total  
Number of Participants  
[units: participants]
  35     36     71  
Age  
[units: years]
Mean ± Standard Deviation
  35.7  ± 11.1     37.1  ± 10.7     36.4  ± 10.9  
Gender  
[units: participants]
     
Female     21     25     46  
Male     14     11     25  



  Outcome Measures
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1.  Primary:   Maximum Papillae   [ Time Frame: Baseline (Day 0), Month 3 ]

2.  Primary:   Maximum Eyelid Hyperaemia   [ Time Frame: Baseline (Day 0), Month 3 ]

3.  Primary:   Mean Upper Eyelid Redness   [ Time Frame: Baseline (Day 0), Month 3 ]

4.  Primary:   Mean Upper Eyelid Margin Staining   [ Time Frame: Baseline (Day 0), Month 3 ]

5.  Secondary:   Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)   [ Time Frame: 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: NCT01594294     History of Changes
Other Study ID Numbers: M-11-09
Study First Received: May 7, 2012
Results First Received: June 27, 2014
Last Updated: June 27, 2014
Health Authority: United Kingdom: Research Ethics Committee