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Trial record 74 of 152 for:    Brimonidine

A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01863953
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions Drug: Fixed-Combination Bimatoprost/Brimonidine
Drug: Bimatoprost Ophthalmic Solution 0.01%
Drug: Vehicle Ophthalmic Solution
Drug: Brimonidine Tartrate Ophthalmic Solution 0.2%
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Hide Arm/Group Description One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Period Title: Overall Study
Started 38 36 38
Completed 38 36 37
Not Completed 0 0 1
Reason Not Completed
Adverse Event             0             0             1
Arm/Group Title Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2% Total
Hide Arm/Group Description One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 38 36 38 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 36 participants 38 participants 112 participants
<45 years 1 0 0 1
Between 45 and 65 years 21 14 20 55
>65 years 16 22 18 56
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 36 participants 38 participants 112 participants
Female
20
  52.6%
22
  61.1%
25
  65.8%
67
  59.8%
Male
18
  47.4%
14
  38.9%
13
  34.2%
45
  40.2%
1.Primary Outcome
Title Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)
Hide Description IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time Frame Baseline, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment
Arm/Group Title Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Hide Arm/Group Description:
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Overall Number of Participants Analyzed 38 36 38
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline 24.54  (1.712) 24.38  (2.022) 24.29  (1.457)
Change from Baseline at Day 42 (N=38, 36, 37) -6.79  (2.277) -6.63  (2.284) -3.92  (2.574)
2.Secondary Outcome
Title Change From Baseline in Average Eye Mean Diurnal IOP
Hide Description IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).
Time Frame Baseline, Day 14, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment
Arm/Group Title Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Hide Arm/Group Description:
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Overall Number of Participants Analyzed 38 36 38
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 24.54  (1.712) 24.38  (2.022) 24.29  (1.457)
Change from Baseline at Day 14 -7.63  (2.152) -6.79  (1.997) -4.67  (2.944)
Change from Baseline at Day 28 -7.25  (2.328) -6.98  (2.260) -4.22  (2.869)
3.Secondary Outcome
Title Average Eye Mean Diurnal IOP
Hide Description IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.
Time Frame Day 14, Day 28, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment
Arm/Group Title Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Hide Arm/Group Description:
One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Overall Number of Participants Analyzed 38 36 38
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 14 16.91  (2.004) 17.59  (2.363) 19.61  (2.572)
Day 28 17.29  (2.588) 17.40  (2.549) 20.06  (2.540)
Day 42 (N=38, 36, 37) 17.75  (2.505) 17.76  (2.467) 20.34  (2.218)
Time Frame [Not Specified]
Adverse Event Reporting Description Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
 
Arm/Group Title Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Hide Arm/Group Description One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
All-Cause Mortality
Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   1/36 (2.78%)   1/38 (2.63%) 
Cardiac disorders       
Acute Myocardial Infarction  1  0/38 (0.00%)  0/36 (0.00%)  1/38 (2.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer  1  0/38 (0.00%)  1/36 (2.78%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fixed-Combination Bimatoprost/Brimonidine Bimatoprost Ophthalmic Solution 0.01% and Vehicle Brimonidine Tartrate Ophthalmic Solution 0.2%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/38 (71.05%)   25/36 (69.44%)   20/38 (52.63%) 
Eye disorders       
Conjunctival Hyperaemia  1  18/38 (47.37%)  16/36 (44.44%)  2/38 (5.26%) 
Eye Pruritus * 1  5/38 (13.16%)  5/36 (13.89%)  3/38 (7.89%) 
Eye Discharge * 1  3/38 (7.89%)  1/36 (2.78%)  1/38 (2.63%) 
Blepharospasm  1  3/38 (7.89%)  0/36 (0.00%)  0/38 (0.00%) 
Punctate Keratitis  1  2/38 (5.26%)  4/36 (11.11%)  2/38 (5.26%) 
Eye Pain * 1  2/38 (5.26%)  1/36 (2.78%)  2/38 (5.26%) 
Foreign Body Sensation in Eyes * 1  2/38 (5.26%)  0/36 (0.00%)  1/38 (2.63%) 
Vision Blurred * 1  1/38 (2.63%)  1/36 (2.78%)  2/38 (5.26%) 
Eye Irritation * 1  0/38 (0.00%)  3/36 (8.33%)  1/38 (2.63%) 
Gastrointestinal disorders       
Dry Mouth * 1  0/38 (0.00%)  1/36 (2.78%)  4/38 (10.53%) 
General disorders       
Instillation Site Pruritus * 1  2/38 (5.26%)  1/36 (2.78%)  0/38 (0.00%) 
Instillation Site Lacrimation * 1  2/38 (5.26%)  0/36 (0.00%)  0/38 (0.00%) 
Infections and infestations       
Nasopharyngitis * 1  0/38 (0.00%)  2/36 (5.56%)  0/38 (0.00%) 
Musculoskeletal and connective tissue disorders       
Spinal Column Stenosis  1  0/38 (0.00%)  0/36 (0.00%)  2/38 (5.26%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 16.1
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: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01863953     History of Changes
Other Study ID Numbers: 192024-082
First Submitted: May 24, 2013
First Posted: May 29, 2013
Results First Submitted: January 16, 2015
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015