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Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01479374
First received: November 22, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
Results First Received: March 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergic Conjunctivitis
Interventions: Drug: AL-4943A ophthalmic solution
Other: AL-4943A vehicle
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%

  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
Patients were recruited from three US study centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 397 enrolled, 195 subjects did not qualify for treatment and were exited without exposure to product. Participant flow and baseline characteristics are presented for the 202 subjects qualifying for treatment and randomized 1:1:1 to receive AL-4943A, Vehicle, or Pataday.

Reporting Groups
  Description
AL-4943A AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
Vehicle AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
Pataday Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days

Participant Flow:   Overall Study
    AL-4943A     Vehicle     Pataday  
STARTED     66     68     68  
COMPLETED     63     60     63  
NOT COMPLETED     3     8     5  
Adverse Event                 2                 1                 0  
Lost to Follow-up                 1                 2                 0  
Decision Unrelated to Adverse Event                 0                 1                 0  
Other                 0                 4                 5  



  Baseline Characteristics
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Reporting Groups
  Description
AL-4943A AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
Vehicle AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
Pataday Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
Total Total of all reporting groups

Baseline Measures
    AL-4943A     Vehicle     Pataday     Total  
Number of Participants  
[units: participants]
 		  66     68     68     202  
Age, Customized  
[units: participants]
 		       
18 to 64 years     64     66     66     196  
>=65 years     2     2     2     6  
Gender  
[units: participants]
 		       
Female     43     39     42     124  
Male     23     29     26     78  
Region of Enrollment  
[units: participants]
 		       
United States     66     68     68     202  



  Outcome Measures
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1.  Primary:   Mean Ocular Itching at Onset of Action   [ Time Frame: Day 21 ]
  Show Outcome Measure 1

2.  Primary:   Mean Ocular Itching at 16 Hours Duration of Action   [ Time Frame: Day 14 ]
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3.  Secondary:   Mean Conjunctival Redness at Onset of Action   [ Time Frame: Day 21 ]
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4.  Secondary:   Mean Conjunctival Redness at 16 Hours Duration of Action   [ Time Frame: Day 14 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Total Redness at 24 Hours Duration of Action   [ Time Frame: Day 1 ]
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6.  Secondary:   Mean Ocular Itching at 24 Hours Duration of Action   [ Time Frame: Day 1 ]
  Show Outcome Measure 6

7.  Secondary:   Mean Conjunctival Redness at 24 Hours Duration of Action   [ Time Frame: Day 1 ]
  Show Outcome Measure 7


  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
No text entered.  


Results Point of Contact:  
Name/Title: Abhijit Narvekar, MS, MBBS
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01479374     History of Changes
Other Study ID Numbers: C-10-126
Study First Received: November 22, 2011
Results First Received: March 28, 2013
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board