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Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00586664
First received: December 21, 2007
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
Results First Received: October 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Allergic Conjunctivitis
Interventions: Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%
Drug: placebo comparator
Drug: Bepotastine Besilate Ophthalmic Solution 1.0%

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
Placebo 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
Bepotastine Besilate Ophthalmic Solution 1.0% 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points

Participant Flow:   Overall Study
    Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%     Placebo     Bepotastine Besilate Ophthalmic Solution 1.0%  
STARTED     43     43     44  
COMPLETED     38     36     43  
NOT COMPLETED     5     7     1  
Withdrawal by Subject                 3                 7                 1  
Exclusion criteria met                 2                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
Placebo 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
Bepotastine Besilate Ophthalmic Solution 1.0% 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
Total Total of all reporting groups

Baseline Measures
    Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%     Placebo     Bepotastine Besilate Ophthalmic Solution 1.0%     Total  
Number of Participants  
[units: participants]
 		  43     43     44     130  
Age  
[units: years]
Mean ± Standard Deviation 		  33.3  ± 15.1     33.3  ± 14.1     34.8  ± 14.0     33.8  ± 14.3  
Gender  
[units: participants]
 		       
Female     21     29     25     75  
Male     22     14     19     55  



  Outcome Measures
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1.  Primary:   Ocular Itching   [ Time Frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
  Show Outcome Measure 1

2.  Primary:   Conjunctival Redness   [ Time Frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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3.  Secondary:   Ciliary Redness   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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4.  Secondary:   Episcleral Redness   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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5.  Secondary:   Chemosis   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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6.  Secondary:   Eyelid Swelling   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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7.  Secondary:   Rhinorrhea (Runny Nose)   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
  Show Outcome Measure 7

8.  Secondary:   Nasal Pruritus (Itchy Nose)   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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9.  Secondary:   Ear or Palate Pruritus (Itchy Ear or Palate)   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
  Show Outcome Measure 9

10.  Secondary:   Nasal Congestion   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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11.  Secondary:   Total Non-Ocular Composite Symptom   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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12.  Secondary:   Tearing   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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13.  Secondary:   Ocular Mucus Discharge   [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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


No publications provided by Bausch & Lomb Incorporated

Publications automatically indexed to this study:


Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00586664     History of Changes
Other Study ID Numbers: CL-S&E-0409071-P
Study First Received: December 21, 2007
Results First Received: October 8, 2009
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration