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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bimatoprost eye drops
placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic glaucoma or ocular hypertension
  • IOP controlled on Xalatan

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Known hypersensitivity to study medications

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

bimatoprost eye drops

placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
September 28, 2007
Last Updated
April 10, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00538304
Brief Title
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
bimatoprost eye drops
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
bimatoprost eye drops
Intervention Description
1 drop in each eye daily for 1 month
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 drop in each eye daily for 1 month
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1
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
Secondary Outcome Measure Information:
Title
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1
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
Title
Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1
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
Title
Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1
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
Title
Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1
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
Title
Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic glaucoma or ocular hypertension IOP controlled on Xalatan Exclusion Criteria: Uncontrolled medical conditions Known hypersensitivity to study medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Atlanta
State/Province
Georgia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21188155
Citation
Craven ER, Liu CC, Batoosingh A, Schiffman RM, Whitcup SM. A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost. Clin Ophthalmol. 2010 Dec 6;4:1433-40. doi: 10.2147/OPTH.S14915.
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A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

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