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Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00818805
First received: January 7, 2009
Last updated: May 29, 2012
Last verified: March 2010
History of Changes
Results First Received: December 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Allergic Conjunctivitis
Interventions: Drug: Olopatadine 0.1%
Drug: Tranilast 0.5%
Drug: Placebo (Olopatadine)
Drug: Placebo (Tranilast)

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population No text entered.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  50  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     50  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     35  
Male     15  



  Outcome Measures

1.  Primary:   Change in “Ocular Itching” Score (5-point Scale) in Subjective Symptom Questionnaire   [ Time Frame: 0-180 minutes after entering the examination room ]
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2.  Secondary:   Change in Total Score in Ocular Symptom Questionnaire   [ Time Frame: 15-180 min. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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 NOT 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.


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
Technical problems with measurement leading to unreliable or uninterpretable data.  


Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Labs
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00818805     History of Changes
Other Study ID Numbers: AL-292ET
Study First Received: January 7, 2009
Results First Received: December 3, 2009
Last Updated: May 29, 2012
Health Authority: Japan: Institutional Review Board