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Safety and Tolerability of Artificial Tears in Dry Eye Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00932477
First received: July 1, 2009
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
Results First Received: November 9, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Dry Eye Syndrome
Interventions: Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Drug: Glycerin and Polysorbate 80 based artificial tear

  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
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 products in a randomly assigned order. The subject used 1 product at a time for a duration of 1 week before switching to the next assigned product (e.g., with treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA).

Reporting Groups
  Description
Sequence ABC Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
Sequence ACB Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
Sequence BAC Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
Sequence BCA Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
Sequence CAB Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
Sequence CBA Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1

Participant Flow for 3 periods

 Period 1:   Treatment 1
    Sequence ABC     Sequence ACB     Sequence BAC     Sequence BCA     Sequence CAB     Sequence CBA  
STARTED     7     8     9     7     8     8  
COMPLETED     7     8     9     7     8     8  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Treatment 2
    Sequence ABC     Sequence ACB     Sequence BAC     Sequence BCA     Sequence CAB     Sequence CBA  
STARTED     7     8     9     7     8     8  
COMPLETED     7     8     9     7     8     8  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Treatment 3
    Sequence ABC     Sequence ACB     Sequence BAC     Sequence BCA     Sequence CAB     Sequence CBA  
STARTED     7     8     9     7     8     8  
COMPLETED     7     8     9     7     8     8  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Tolerability Questionnaire Mean Scores at 1 Week   [ Time Frame: 1 Week ]
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2.  Secondary:   Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week   [ Time Frame: 1 Week ]
  Show Outcome Measure 2

3.  Secondary:   Best-Corrected Visual Acuity (BCVA) Status at 1 Week   [ Time Frame: 1 Week ]
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4.  Secondary:   The Number of Ophthalmic Adverse Events at 1 Week   [ Time Frame: 1 Week ]
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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
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00932477     History of Changes
Other Study ID Numbers: AG9965-001
Study First Received: July 1, 2009
Results First Received: November 9, 2011
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board