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A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT00538304
Recruitment Status : Completed
First Posted : October 2, 2007
Results First Posted : October 27, 2011
Last Update Posted : October 27, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions Drug: bimatoprost eye drops
Drug: placebo
Enrollment 222
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description Bimatoprost eye drops Placebo
Period Title: Overall Study
Started 151 71
Completed 144 66
Not Completed 7 5
Arm/Group Title Bimatoprost Eye Drops Placebo Total
Hide Arm/Group Description Bimatoprost eye drops Placebo Total of all reporting groups
Overall Number of Baseline Participants 151 71 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 71 participants 222 participants
< 45 years 9 2 11
Between 45 and 65 years 66 32 98
> 65 years 76 37 113
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 71 participants 222 participants
Female
91
  60.3%
44
  62.0%
135
  60.8%
Male
60
  39.7%
27
  38.0%
87
  39.2%
1.Primary Outcome
Title Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
Hide Description Change from Baseline in macroscopic conjunctival hyperemia (or visible eye redness). Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). The peak change is calculated for each eye by subtracting the largest score across the hourly measurements at baseline from the largest score across the hourly measurements at month 1. A positive number severity grade change from baseline indicated an increase in redness.
Time Frame Baseline, Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description:
Bimatoprost eye drops
Placebo
Overall Number of Participants Analyzed 147 71
Mean (Standard Deviation)
Unit of Measure: Number on a scale (score)
Baseline 0.32  (0.280) 0.30  (0.288)
Month 1 0.18  (0.456) 0.02  (0.321)
2.Secondary Outcome
Title Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1
Hide Description Percentage of patients with a >= 1 unit increase in macroscopic conjunctival hyperemia in either eye at the Month 1, 8 AM time point. Macroscopic conjunctival hyperemia is graded by the investigator who compares the patient’s visual appearance of eye redness to standard photographs using a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe).
Time Frame Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description:
Bimatoprost eye drops
Placebo
Overall Number of Participants Analyzed 147 71
Measure Type: Number
Unit of Measure: Percentage of Patients
8.16 1.41
3.Secondary Outcome
Title Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
Hide Description Change from baseline in mean (average) IOP at Month 1 8 AM timepoint. IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Time Frame Baseline, Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description:
Bimatoprost eye drops
Placebo
Overall Number of Participants Analyzed 147 71
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)
Baseline, 8AM 18.2  (3.13) 18.0  (3.34)
Month 1, 8AM -1.0  (2.64) 3.6  (3.85)
4.Secondary Outcome
Title Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
Hide Description Percentage of physicians who were very or extremely willing to continue patient on drug if drug were marketed based on their reported response to the question. Physicians were asked “Overall, based on how well this drug lowered THIS patient’s IOP, balanced with any adverse events she/he may have experienced, would you consider continuing THIS medication (if the drug was marketed)?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, physician was asked for reason.
Time Frame Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description:
Bimatoprost eye drops
Placebo
Overall Number of Participants Analyzed 147 71
Measure Type: Number
Unit of Measure: Percentage of Physicians
85.7 39.5
5.Secondary Outcome
Title Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
Hide Description Percentage of patients who were very or extremely willing to continue to use this glaucoma medication based on their reported response to the question. Patients were asked “Overall, based on how well this drug lowered your IOP, your concern about the preservation of your vision, balanced with any side effects you may have experienced using your medication, would you be willing to continue this medication (eye drops) if your physician prescribed it?”. The responses were extremely willing, very willing, somewhat willing and not willing. If not willing, patient was asked for reason.
Time Frame Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description:
Bimatoprost eye drops
Placebo
Overall Number of Participants Analyzed 147 71
Measure Type: Number
Unit of Measure: Percentage of Patients
88.5 52.9
6.Secondary Outcome
Title Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1
Hide Description Percentage of patients who reported no change in the appearance of their eyes since the beginning of the study. Patients were asked “Are you experiencing a change in how your eye looks now since you began your current glaucoma medication?”. The responses were yes or no. If yes, patient was asked for primary reason and if better, worse or as expected based on what the doctor’s office told them to expect.
Time Frame Month 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who were enrolled in the study, received at least 1 dose of study medication and were evaluated for macroscopic conjunctival hyperemia at baseline and the month 1 visits.
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description:
Bimatoprost eye drops
Placebo
Overall Number of Participants Analyzed 147 71
Measure Type: Number
Unit of Measure: Percentage of Patients
95.1 94.1
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population consisted of all patients who were randomized, received at least 1 dose of masked study medication and had at least 1 post-baseline visit.
 
Arm/Group Title Bimatoprost Eye Drops Placebo
Hide Arm/Group Description Bimatoprost eye drops Placebo
All-Cause Mortality
Bimatoprost Eye Drops Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bimatoprost Eye Drops Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/71 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimatoprost Eye Drops Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/150 (6.67%)   2/71 (2.82%) 
Eye disorders     
Conjunctival hyperaemia  1  10/150 (6.67%)  2/71 (2.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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: NCT00538304     History of Changes
Other Study ID Numbers: 192024-035
First Submitted: September 28, 2007
First Posted: October 2, 2007
Results First Submitted: September 19, 2011
Results First Posted: October 27, 2011
Last Update Posted: October 27, 2011