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A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

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ClinicalTrials.gov Identifier: NCT01594970
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Glaucoma, Open-Angle
Ocular Hypertension
Intervention Drug: Bimatoprost 0.01%
Enrollment 800
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Hide Arm/Group Description 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Period Title: Overall Study
Started 295 248 257
Completed 220 166 191
Not Completed 75 82 66
Reason Not Completed
Non-Adverse Event Related             4             5             6
Adverse Event             17             23             23
Lost to Follow-up             54             54             37
Arm/Group Title Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy) Total
Hide Arm/Group Description 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 295 248 257 800
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 295 participants 248 participants 257 participants 800 participants
58.0  (13.81) 59.5  (13.23) 61.2  (12.59) 59.5  (13.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 295 participants 248 participants 257 participants 800 participants
Female
130
  44.1%
145
  58.5%
105
  40.9%
380
  47.5%
Male
165
  55.9%
103
  41.5%
152
  59.1%
420
  52.5%
1.Primary Outcome
Title Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
Hide Description Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all treated subjects with data at this time point
Arm/Group Title Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Hide Arm/Group Description:
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Overall Number of Participants Analyzed 220 166 191
Measure Type: Number
Unit of Measure: Participants
None 40 49 20
Trace 71 54 70
Mild 73 47 65
Moderate 31 11 30
Severe 5 5 6
2.Secondary 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).
Time Frame Baseline, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all treated subjects
Arm/Group Title Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Hide Arm/Group Description:
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Overall Number of Participants Analyzed 295 248 257
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline 18.6  (5.39) 17.0  (5.73) 19.3  (6.19)
Change from Baseline at Week 6 (N=251, 204, 233) -4.7  (4.50) -2.6  (4.43) -3.2  (5.44)
Change from Baseline at Week 12 (N=220, 165, 191) -4.3  (4.42) -2.8  (4.68) -3.4  (6.11)
3.Secondary Outcome
Title Overall Percent Change From Baseline in IOP
Hide Description IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).
Time Frame Baseline, Week 6, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all treated subjects with data at this time point
Arm/Group Title Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Hide Arm/Group Description:
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Overall Number of Participants Analyzed 295 248 257
Mean (Standard Deviation)
Unit of Measure: Percent Change
Change from Baseline at Week 6 (N=251, 204, 233) -22.09  (17.023) -12.90  (18.912) -14.37  (20.883)
Change from Baseline at Week 12 (N=220, 165, 191) -20.22  (17.566) -12.81  (19.438) -14.25  (23.376)
4.Other Pre-specified Outcome
Title Change From Baseline in Hyperemia Severity in the Study Eye
Hide Description Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all treated subjects with data at this time point
Arm/Group Title Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Hide Arm/Group Description:
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Overall Number of Participants Analyzed 220 166 191
Measure Type: Number
Unit of Measure: Participants
Improved 1 8 15
No Change 191 149 159
Worsened 28 9 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Hide Arm/Group Description 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
All-Cause Mortality
Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/295 (0.34%)   0/248 (0.00%)   1/257 (0.39%) 
Eye disorders       
Glaucoma  1  0/295 (0.00%)  0/248 (0.00%)  1/257 (0.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung Neoplasm Malignant  1  1/295 (0.34%)  0/248 (0.00%)  0/257 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimatoprost 0.01% (Naive Monotherapy) Bimatoprost 0.01% (Switched Monotherapy) Bimatoprost 0.01% (With Adjunctive Therapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/295 (2.37%)   9/248 (3.63%)   14/257 (5.45%) 
Eye disorders       
Conjunctival Hyperaemia  1  7/295 (2.37%)  9/248 (3.63%)  14/257 (5.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.1
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 at least 30 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: Allergan
ClinicalTrials.gov Identifier: NCT01594970     History of Changes
Other Study ID Numbers: APMA-001211
First Submitted: May 8, 2012
First Posted: May 9, 2012
Results First Submitted: January 27, 2014
Results First Posted: March 12, 2014
Last Update Posted: March 12, 2014