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Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00938704
First received: July 10, 2009
Last updated: September 22, 2011
Last verified: September 2011
Results First Received: September 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Dry Eye Syndromes
Interventions: Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
Drug: sodium hyaluronate 0.18%

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Carboxymethylcellulose 0.5%, Glycerin 0.9% carboxymethylcellulose 0.5%, glycerin 0.9%
Sodium Hyaluronate 0.18% sodium hyaluronate 0.18%

Participant Flow:   Overall Study
    Carboxymethylcellulose 0.5%, Glycerin 0.9%     Sodium Hyaluronate 0.18%  
STARTED     33     37  
COMPLETED     33     37  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Carboxymethylcellulose 0.5%, Glycerin 0.9% carboxymethylcellulose 0.5%, glycerin 0.9%
Sodium Hyaluronate 0.18% sodium hyaluronate 0.18%
Total Total of all reporting groups

Baseline Measures
    Carboxymethylcellulose 0.5%, Glycerin 0.9%     Sodium Hyaluronate 0.18%     Total  
Number of Participants  
[units: participants]
  33     37     70  
Age  
[units: years]
Mean ( Full Range )
  54.386  
  ( 20.277 to 87.485 )  
  48.787  
  ( 18.942 to 84.482 )  
  51.5865  
  ( 18.942 to 87.485 )  
Gender  
[units: participants]
     
Female     23     28     51  
Male     10     9     19  



  Outcome Measures
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1.  Primary:   Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2   [ Time Frame: Baseline, Week 2 ]

2.  Secondary:   Change From Baseline in Tear Breakup Time (TBUT) at Week 2   [ Time Frame: Baseline, Week 2 ]

3.  Secondary:   Change From Baseline in Corneal Staining at Week 2   [ Time Frame: Baseline, Week 2 ]

4.  Secondary:   Change From Baseline in Conjunctival Staining (Temporal) at Week 2   [ Time Frame: Baseline, Week 2 ]

5.  Secondary:   Change From Baseline in Conjunctival Staining (Nasal) at Week 2   [ Time Frame: Baseline, Week 2 ]


  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: Vice President Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00938704     History of Changes
Other Study ID Numbers: MA-OPT-09-002
Study First Received: July 10, 2009
Results First Received: September 22, 2011
Last Updated: September 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices