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
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma Ocular Hypertension||Drug: bimatoprost eye drops Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
bimatoprost eye drops
Drug: bimatoprost eye drops
1 drop in each eye daily for 1 month
Placebo Comparator: 2
1 drop in each eye daily for 1 month
- Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 [ Time Frame: Baseline, Month 1 ]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.
- Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1 [ Time Frame: Month 1 ]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).
- Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1 [ Time Frame: Baseline, Month 1 ]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.
- Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1 [ Time Frame: Month 1 ]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.
- Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1 [ Time Frame: Month 1 ]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.
- Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1 [ Time Frame: Month 1 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538304
|United States, Georgia|
|Atlanta, Georgia, United States|
|Study Director:||Medical Director||Allergan|