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Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

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ClinicalTrials.gov Identifier: NCT01243567
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : February 26, 2013
Last Update Posted : April 18, 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
Condition Glaucoma, Open-Angle
Interventions Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Drug: latanoprost 0.005% ophthalmic solution
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Period Title: Overall Study
Started 43 38
Completed 42 38
Not Completed 1 0
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution Total
Hide Arm/Group Description Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months. Total of all reporting groups
Overall Number of Baseline Participants 43 38 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 38 participants 81 participants
65.9  (10.24) 63.1  (13.72) 64.6  (12.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 38 participants 81 participants
Female
20
  46.5%
18
  47.4%
38
  46.9%
Male
23
  53.5%
20
  52.6%
43
  53.1%
1.Primary Outcome
Title Change From Baseline in Average Intraocular Pressure (IOP)
Hide Description IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients.
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description:
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Overall Number of Participants Analyzed 43 38
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline 28.4  (3.35) 28.5  (2.57)
Change from Baseline at Month 3 -13.5  (4.48) -11.4  (3.19)
2.Secondary Outcome
Title Change From Baseline IOP
Hide Description IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients.
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description:
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Overall Number of Participants Analyzed 43 38
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline-08:00 29.7  (2.97) 29.6  (2.93)
Baseline-12:00 28.7  (4.46) 29.0  (2.60)
Baseline-16:00 26.8  (4.01) 26.8  (3.73)
Change from Baseline at Month 3-08:00 -14.6  (4.04) -12.3  (3.64)
Change from Baseline at Month 3-12:00 -13.6  (5.50) -11.8  (3.14)
Change from Baseline at Month 3-16:00 -12.4  (5.16) -10.3  (4.24)
3.Secondary Outcome
Title Percentage of Patients Reaching a Predefined Target Pressure Threshold
Hide Description IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients.
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description:
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Overall Number of Participants Analyzed 43 38
Measure Type: Number
Unit of Measure: Percentage of Patients
Decrease of at Least 20% 97.7 100.0
Decrease of at Least 30% 90.7 86.8
Decrease of at Least 40% 74.4 47.4
Decrease of at Least 50% 46.5 15.8
4.Secondary Outcome
Title Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Hide Description IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients.
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description:
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Overall Number of Participants Analyzed 43 38
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline 30.4  (3.19) 30.3  (2.54)
Absolute Difference at Month 3 -15.3  (4.44) -12.9  (3.82)
5.Secondary Outcome
Title Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Hide Description IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients.
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description:
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Overall Number of Participants Analyzed 43 38
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline 26.2  (4.04) 26.5  (3.44)
Absolute Difference at Month 3 -11.8  (5.23) -9.9  (3.71)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Hide Arm/Group Description Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
All-Cause Mortality
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   1/43 (2.33%)   0/38 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon Cancer  1  1/43 (2.33%)  0/38 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   9/43 (20.93%)   10/38 (26.32%) 
Eye disorders     
Ocular Hyperaemia * 1  7/43 (16.28%)  4/38 (10.53%) 
Blepharitis * 1  1/43 (2.33%)  2/38 (5.26%) 
Conjunctival Hyperaemia  1  1/43 (2.33%)  2/38 (5.26%) 
Foreign Body Sensation in Eyes * 1  0/43 (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 12.1
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
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: NCT01243567    
Other Study ID Numbers: MAF-AGN-OPH-GLA-010
2009-012799-28 ( EudraCT Number )
First Submitted: November 17, 2010
First Posted: November 18, 2010
Results First Submitted: January 22, 2013
Results First Posted: February 26, 2013
Last Update Posted: April 18, 2019