Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00611403
First received: January 28, 2008
Last updated: November 17, 2011
Last verified: November 2011
Results First Received: November 17, 2011  
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: Dry Eye Syndromes
Interventions: Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Drug: Artificial Tears REFRESH ENDURA®

  Participant Flow
  Hide Participant Flow

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
RESTASIS® Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA® Artificial Tears (REFRESH ENDURA®)

Participant Flow for 2 periods

Period 1:   Treatment Phase
    RESTASIS®     REFRESH ENDURA®  
STARTED     68     69  
COMPLETED     62     58  
NOT COMPLETED     6     11  

Period 2:   Post Treatment Extension Phase
    RESTASIS®     REFRESH ENDURA®  
STARTED     26 [1]   25 [2]
COMPLETED     22     24  
NOT COMPLETED     4     1  
[1] 26 of 68 pts who received RESTASIS® in the Treatment Phase entered the Post Treatment Ext. Phase
[2] 25 of 69 pts who received ENDURA® in the Treatment Phase entered the Post Treatment Extension Phase



  Baseline Characteristics
  Hide Baseline Characteristics

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
RESTASIS® Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA® Artificial Tears (REFRESH ENDURA®)
Total Total of all reporting groups

Baseline Measures
    RESTASIS®     REFRESH ENDURA®     Total  
Number of Participants  
[units: participants]
  68     69     137  
Age, Customized  
[units: participants]
     
< 30 years     19     21     40  
Between 30 and 40 years     25     24     49  
> 40 years     24     24     48  
Gender  
[units: participants]
     
Female     43     36     79  
Male     25     33     58  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients With Clinical Success at Month 6   [ Time Frame: Month 6 ]

2.  Secondary:   Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6   [ Time Frame: Baseline, Month 6 ]

3.  Secondary:   Change From Baseline in Goblet Cell Density of the Eyes at Month 6   [ Time Frame: Baseline, Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Therapeutic Area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00611403     History of Changes
Other Study ID Numbers: 192371-014
Study First Received: January 28, 2008
Results First Received: November 17, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration