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Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

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ClinicalTrials.gov Identifier: NCT01170884
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : January 12, 2012
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
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; bimatoprost 0.03% ophthalmic solution
Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combigan® + Lumigan® Lumigan®
Hide Arm/Group Description COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution) LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
Period Title: Overall Study
Started 59 62
Completed 54 60
Not Completed 5 2
Arm/Group Title Combigan® + Lumigan® Lumigan® Total
Hide Arm/Group Description COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution) LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes Total of all reporting groups
Overall Number of Baseline Participants 59 62 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 62 participants 121 participants
64.0  (10.52) 62.6  (13.19) 63.3  (11.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 62 participants 121 participants
Female
28
  47.5%
36
  58.1%
64
  52.9%
Male
31
  52.5%
26
  41.9%
57
  47.1%
1.Primary Outcome
Title Mean Diurnal Intraocular Pressure (IOP) at Week 12
Hide Description Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. 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 (ITT) included all subjects who were randomized to study medication.
Arm/Group Title Combigan® + Lumigan® Lumigan®
Hide Arm/Group Description:
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
Overall Number of Participants Analyzed 59 62
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mm Hg)
15.4  (2.34) 19.2  (3.42)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combigan® + Lumigan® Lumigan®
Hide Arm/Group Description COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution) LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
All-Cause Mortality
Combigan® + Lumigan® Lumigan®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Combigan® + Lumigan® Lumigan®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/62 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combigan® + Lumigan® Lumigan®
Affected / at Risk (%) Affected / at Risk (%)
Total   10/59 (16.95%)   1/62 (1.61%) 
Eye disorders     
Foreign Body Sensation *  3/59 (5.08%)  0/62 (0.00%) 
Ocular Redness *  7/59 (11.86%)  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Vice President, Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01170884    
Other Study ID Numbers: GMA-COM-09-013
First Submitted: July 26, 2010
First Posted: July 27, 2010
Results First Submitted: December 7, 2011
Results First Posted: January 12, 2012
Last Update Posted: April 24, 2019