Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01547598
First received: February 10, 2012
Last updated: July 28, 2014
Last verified: July 2014
Results First Received: July 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Interventions: Drug: travoprost ophthalmic solution 0.004%
Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution
Drug: Bimatoprost ophthalmic solution 0.01%

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LUMIGAN® RC Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
DuoTrav® Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.

Participant Flow:   Overall Study
    LUMIGAN® RC     DuoTrav®  
STARTED     67     68  
COMPLETED     61     63  
NOT COMPLETED     6     5  
Withdrew consent                 1                 1  
Lost to Follow-up                 1                 1  
Adverse Event                 1                 1  
Protocol Violation                 1                 1  
Other Miscellaneous Reasons                 2                 1  



  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.
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Reporting Groups
  Description
LUMIGAN® RC Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
DuoTrav® Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    LUMIGAN® RC     DuoTrav®     Total  
Number of Participants  
[units: participants]
  67     68     135  
Age  
[units: Years]
Mean ± Standard Deviation
  67.2  ± 9.7     65.2  ± 10.7     66.2  ± 10.3  
Gender  
[units: Participants]
     
Female     40     40     80  
Male     27     28     55  



  Outcome Measures
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1.  Primary:   Mean Diurnal Intraocular Pressure (IOP)   [ Time Frame: Week 12 ]

2.  Secondary:   Change From Baseline in Mean IOP at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg   [ Time Frame: Week 12 ]

5.  Secondary:   Change From Baseline in Mean IOP at Week 6   [ Time Frame: Baseline, Week 6 ]


  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: NCT01547598     History of Changes
Other Study ID Numbers: GMA-LUM-11-020
Study First Received: February 10, 2012
Results First Received: July 28, 2014
Last Updated: July 28, 2014
Health Authority: Canada: Ethics Review Committee