7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00884806
First received: April 17, 2009
Last updated: March 21, 2012
Last verified: March 2012
Results First Received: February 20, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Contact Lens Care
Interventions: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Device: Etafilcon A contact lens (ACUVUE® 2™)
Device: Senofilcon A contact lens (ACUVUE® OASYS™)
Device: Lotrafilcon B contact lens (O2 OPTIX®)
Device: Balafilcon A contact lens (PureVision®)

  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 6 US study centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
110 participants with normal eyes (other than vision correction) were enrolled in the study. After the screening visit, particpants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to the baseline/dispensing visit.

Reporting Groups
  Description
FID 114675A FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.

Participant Flow:   Overall Study
    FID 114675A  
STARTED     110  
COMPLETED     110  
NOT COMPLETED     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.
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Reporting Groups
  Description
FID 114675A FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.

Baseline Measures
    FID 114675A  
Number of Participants  
[units: participants]
  110  
Age  
[units: years]
Mean ± Standard Deviation
  33.1  ± 11.1  
Gender  
[units: participants]
 
Female     81  
Male     29  



  Outcome Measures
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1.  Primary:   Solution-Related Corneal Staining   [ Time Frame: Day 7 ]

2.  Secondary:   Mean Lens Comfort   [ Time Frame: Day 7 ]


  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: NCT00884806     History of Changes
Other Study ID Numbers: C-08-081
Study First Received: April 17, 2009
Results First Received: February 20, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board