Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00811564
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : September 21, 2011
Last Update Posted : September 21, 2011
Sponsor:
Information provided by:
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
Drug: latanoprost 0.005%
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution Latanoprost 0.005% ophthalmic solution
Period Title: Overall Study
Started 73 75
Completed 64 73
Not Completed 9 2
Arm/Group Title Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Latanoprost 0.005% Ophthalmic Solution Total
Hide Arm/Group Description Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution Latanoprost 0.005% ophthalmic solution Total of all reporting groups
Overall Number of Baseline Participants 73 75 148
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 73 participants 75 participants 148 participants
65
(27 to 88)
65
(33 to 87)
65
(27 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 75 participants 148 participants
Female
42
  57.5%
44
  58.7%
86
  58.1%
Male
31
  42.5%
31
  41.3%
62
  41.9%
1.Primary Outcome
Title Intraocular Pressure (IOP) at Week 12
Hide Description Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, which included all patients who started the study (randomized).
Arm/Group Title Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description:
Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Latanoprost 0.005% ophthalmic solution
Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mm Hg)
17.75  (2.878) 17.90  (3.943)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.
 
Arm/Group Title Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution Latanoprost 0.005% ophthalmic solution
All-Cause Mortality
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Latanoprost 0.005% Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Latanoprost 0.005% Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)   1/75 (1.33%) 
Blood and lymphatic system disorders     
Anemia  1  0/73 (0.00%)  1/75 (1.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART version 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Latanoprost 0.005% Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   8/73 (10.96%)   0/75 (0.00%) 
Eye disorders     
Eye irritation * 1  4/73 (5.48%)  0/75 (0.00%) 
Pain eye * 1  4/73 (5.48%)  0/75 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, COSTART version 6
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.
A 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 90 days from the time submitted to the sponsor for review. 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
Responsible Party: Medical Affairs Director, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00811564     History of Changes
Other Study ID Numbers: GMA-COM-08-008
First Submitted: December 17, 2008
First Posted: December 19, 2008
Results First Submitted: August 17, 2011
Results First Posted: September 21, 2011
Last Update Posted: September 21, 2011