ESBA105 in Patients With Severe Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01338610
First received: April 18, 2011
Last updated: April 18, 2013
Last verified: April 2013
Results First Received: February 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Eyes Dry Chronic
Interventions: Biological: ESBA105 ophthalmic solution
Other: ESBA105 vehicle

  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
Subjects were recruited from 16 investigative sites located within the United States. Participant flow data is presented for all subjects exposed to product.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 334 enrolled, 210 subjects did not qualify for Run-In and were exited from the study without exposure to product. Of the 124 entering Run-In, 39 did not qualify for treatment. The 85 subjects qualifying for treatment were randomized 2:1 to receive either ESBA105 or Vehicle.

Reporting Groups
  Description
Run-In Only ESBA105 vehicle
ESBA105 ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
Vehicle ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)

Participant Flow:   Overall Study
    Run-In Only     ESBA105     Vehicle  
STARTED     39     56     29  
COMPLETED     34     55     28  
NOT COMPLETED     5     1     1  
Patient Decision Unrelated to Advs Event                 1                 1                 0  
Protocol Violation                 1                 0                 1  
Adverse Event                 3                 0                 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.
Baseline data is presented for all subjects exposed to product.

Reporting Groups
  Description
Run-In Only ESBA105 vehicle
ESBA105 ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
Vehicle ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
Total Total of all reporting groups

Baseline Measures
    Run-In Only     ESBA105     Vehicle     Total  
Number of Participants  
[units: participants]
  39     56     29     124  
Age, Customized  
[units: participants]
       
<65     24     32     21     77  
≥65     15     24     8     47  
Gender  
[units: participants]
       
Female     35     45     26     106  
Male     4     11     3     18  
Region of Enrollment  
[units: participants]
       
United States     39     56     29     124  



  Outcome Measures

1.  Primary:   Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28   [ Time Frame: Up to 28 days ]


  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
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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.


Results Point of Contact:  
Name/Title: Christian Leisner
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: NCT01338610     History of Changes
Other Study ID Numbers: C-10-079
Study First Received: April 18, 2011
Results First Received: February 28, 2013
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration