Comparative Performance of a Bausch & Lomb Multipurpose Solution and Alcon OptiFree Replenish Multipurpose Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00636194
First received: March 7, 2008
Last updated: December 7, 2011
Last verified: December 2011
Results First Received: December 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Condition: Adverse Effect of Contact Lens Solution
Interventions: Device: Bausch & Lomb Multipurpose Solution
Device: Alcon OptiFree Replenish Multipurpose Solution

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
361 subjects (722 eyes) who are currently adapted silicone hydrogel contact lens wearers and are habitually using a lens care product for disinfecting lenses, were enrolled in this 2-Week study at approximately 14 investigative sites in Asia. Study start date was 2/16/2008 and last subject exited on 3/17/2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fourteen Investigators enrolled 361 subjects in the study. Of these subjects, 347 successfully completed the study, 3 discontinued and 11 were ineligible at baseline, but were dispensed study materials

Reporting Groups
  Description
B&L Multipurpose Solution Bausch & Lomb Multipurpose Contact Lens Solution
Alcon Multipurpose Solution Alcon OptiFree Replenish Multipurpose Contact Lens Solution

Participant Flow:   Overall Study
    B&L Multipurpose Solution     Alcon Multipurpose Solution  
STARTED     175     175  
COMPLETED     172     175  
NOT COMPLETED     3     0  
Study related symptoms and complaints                 1                 0  
Protocol Violation                 2                 0  



  Baseline Characteristics
  Hide 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
B&L Multipurpose Solution Bausch & Lomb Multipurpose Contact Lens Solution
Alcon Multipurpose Solution Alcon OptiFree Replenish Multipurpose Contact Lens Solution
Total Total of all reporting groups

Baseline Measures
    B&L Multipurpose Solution     Alcon Multipurpose Solution     Total  
Number of Participants  
[units: participants]
  175     175     350  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     175     175     350  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     125     121     246  
Male     50     54     104  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     175     175     350  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjective Assessment of Comfort and Cleanliness   [ Time Frame: 7 days ]

2.  Secondary:   Symptoms and Complaints   [ Time Frame: 2 weeks ]

3.  Secondary:   Graded Slit Lamp Findings > Grade 2   [ Time Frame: 2 week follow-up visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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: Robert Steffen OD
Organization: Bausch & Lomb
phone: (585) 338-6399
e-mail: robert.steffen@bausch.com


No publications provided


Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00636194     History of Changes
Other Study ID Numbers: 562
Study First Received: March 7, 2008
Results First Received: December 14, 2010
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration