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

Study Overview
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Brief Summary
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A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: bimatoprost eye drops
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic glaucoma or ocular hypertension IOP controlled on Xalatan Exclusion Criteria: Uncontrolled medical conditions Known hypersensitivity to study medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>bimatoprost eye drops | Drug: bimatoprost eye drops<br>* 1 drop in each eye daily for 1 month<br>|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* 1 drop in each eye daily for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at 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. | Baseline, Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at 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). | Month 1 | 
| Change From Baseline in Mean Intraocular Pressure (IOP) at 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. | Baseline, Month 1 | 
| Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at 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. | Month 1 | 
| Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at 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. | Month 1 | 
| Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at 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. | Month 1 |