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Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00586625
First received: December 21, 2007
Last updated: February 13, 2013
Last verified: February 2013
Results First Received: October 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Allergic Conjunctivitis
Interventions: Drug: Bepreve
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% One drop, both eyes, twice a day for six weeks
Placebo (Vehicle) One drop, both eyes, twice a day for six weeks

Participant Flow:   Overall Study
    Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%   Placebo (Vehicle)
STARTED   575   286 
COMPLETED   532   269 
NOT COMPLETED   43   17 
Adverse Event                6                6 
Protocol Violation                3                0 
Withdrawal by Subject                32                10 
Subject non-compliance                0                1 
Subject unable to return for visit                2                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.
No text entered.

Reporting Groups
  Description
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% One drop, both eyes, twice a day for six weeks
Placebo (Vehicle) One drop, both eyes, twice a day for six weeks
Total Total of all reporting groups

Baseline Measures
   Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%   Placebo (Vehicle)   Total 
Overall Participants Analyzed 
[Units: Participants]
 575   286   861 
Age, Customized 
[Units: Participants]
     
3-9 years   47   25   72 
10-17 years   40   15   55 
>=18 years   488   246   734 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.5  (16.5)   34.2  (16.3)   34.4  (16.4) 
Gender 
[Units: Participants]
     
Female   367   178   545 
Male   208   108   316 


  Outcome Measures

1.  Primary:   Ocular Comfort   [ Time Frame: Day 8 & Day 22 ]


  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
No text entered.


  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: Vice President, Clinical Research & Medical Affairs
Organization: ISTA Pharmaceuticals, Inc.
phone: 949-788-6000
e-mail: tmcnamara@istavision.com



Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00586625     History of Changes
Other Study ID Numbers: CL-SAF-0405071-P
Study First Received: December 21, 2007
Results First Received: October 8, 2009
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration