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Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00534794
First received: September 20, 2007
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
Results First Received: January 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Allergic Conjunctivitis
Interventions: Drug: Elestat
Drug: Pataday

  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
Elestat 1 drop each eye for 2 days
Pataday 1 drop each eye for 1 day

Participant Flow:   Overall Study
    Elestat     Pataday  
STARTED     40     39  
COMPLETED     40     39  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Elestat 1 drop each eye for 2 days
Pataday 1 drop each eye for 1 day
Total Total of all reporting groups

Baseline Measures
    Elestat     Pataday     Total  
Number of Participants  
[units: participants]
 		  40     39     79  
Age  
[units: years]
Mean ± Standard Deviation 		  41.3  ± 12.18     40.1  ± 13.41     40.7  ± 12.73  
Gender  
[units: participants]
 		     
Female     20     27     47  
Male     20     12     32  



  Outcome Measures
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1.  Primary:   Change in Ocular Itch Score From Baseline   [ Time Frame: 0 hours, 12 hours ]
  Show Outcome Measure 1

2.  Secondary:   Ocular Comfort Score at 12 Hours   [ Time Frame: 12 hours ]
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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: Saiid Davari – Associate Director, Ophthalmic Clinical Research
Organization: Inspire
phone: 919-941-9777
e-mail: sdavari@inspirepharm.com


No publications provided


Responsible Party: Inspire Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00534794     History of Changes
Other Study ID Numbers: 031-408
Study First Received: September 20, 2007
Results First Received: January 30, 2009
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration