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Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

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ClinicalTrials.gov Identifier: NCT01151904
Recruitment Status : Terminated (Difficulty with patient recruitment)
First Posted : June 29, 2010
Results First Posted : February 6, 2013
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glaucoma, Angle-Closure
Interventions Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution
Drug: latanoprost
Enrollment 17
Recruitment Details Due to lack of enrollment, this study was discontinued early.
Pre-assignment Details  
Arm/Group Title COMBIGAN® With Latanoprost
Hide Arm/Group Description Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title COMBIGAN® With Latanoprost
Hide Arm/Group Description Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants
<45 years 0
Between 45 and 65 years 7
>65 years 10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
12
  70.6%
Male
5
  29.4%
1.Primary Outcome
Title Change From Baseline in Intraocular Pressure (IOP)
Hide Description IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.
Arm/Group Title COMBIGAN® With Latanoprost
Hide Arm/Group Description:
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in IOP
Hide Description IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.
Time Frame Baseline, Week 2, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.
Arm/Group Title COMBIGAN® With Latanoprost
Hide Arm/Group Description:
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Responders With an IOP Reduction ≥20% From Baseline
Hide Description IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.
Arm/Group Title COMBIGAN® With Latanoprost
Hide Arm/Group Description:
Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title COMBIGAN® With Latanoprost
Hide Arm/Group Description Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
All-Cause Mortality
COMBIGAN® With Latanoprost
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
COMBIGAN® With Latanoprost
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
COMBIGAN® With Latanoprost
Affected / at Risk (%)
Total   5/17 (29.41%) 
Eye disorders   
Corneal Erosion   2/17 (11.76%) 
Conjunctival Hyperemia   2/17 (11.76%) 
Nervous system disorders   
Somnolent *  1/17 (5.88%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Due to lack of enrollment, this study was discontinued early and the outcome measures were not analyzed.
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: NCT01151904     History of Changes
Other Study ID Numbers: MA-COM004
First Submitted: June 5, 2010
First Posted: June 29, 2010
Results First Submitted: January 3, 2013
Results First Posted: February 6, 2013
Last Update Posted: February 6, 2013