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Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01187355
First received: August 20, 2010
Last updated: June 26, 2012
Last verified: June 2012
Results First Received: June 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Condition: Symptomatic Contact Lens Wearers
Interventions: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Device: renu fresh Multi-Purpose Solution (MPS)
Device: 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
Subjects were recruited and enrolled from 42 US study centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Participant Flow Chart includes all randomized patients: 591. Baseline characteristics are presented for all subjects who received test article and had at least one on-regimen study visit: 578.

Reporting Groups
  Description
Alcon MPDS Multi-purpose disinfecting contact lens solution
Renu Fresh MPS Multi-purpose contact lens solution

Participant Flow:   Overall Study
    Alcon MPDS     Renu Fresh MPS  
STARTED     294     297  
COMPLETED     276     277  
NOT COMPLETED     18     20  



  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.
No text entered.

Reporting Groups
  Description
Alcon MPDS Multi-purpose disinfecting contact lens solution
Renu Fresh MPS Multi-purpose contact lens solution
Total Total of all reporting groups

Baseline Measures
    Alcon MPDS     Renu Fresh MPS     Total  
Number of Participants  
[units: participants]
  288     290     578  
Age  
[units: years]
Mean ± Standard Deviation
  34.5  ± 11.43     34.0  ± 11.24     34.3  ± 11.33  
Gender  
[units: participants]
     
Female     209     212     421  
Male     79     78     157  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.   [ Time Frame: Day 30 ]

2.  Secondary:   Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.   [ Time Frame: Day 30 ]

3.  Secondary:   Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.   [ Time Frame: Day 30 ]


  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: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01187355     History of Changes
Other Study ID Numbers: C-09-074
Study First Received: August 20, 2010
Results First Received: June 26, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board