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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00538304
First received: September 28, 2007
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Glaucoma
Ocular Hypertension
 Drug: bimatoprost eye drops
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1 [ Time Frame: Baseline, Month 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 222
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
bimatoprost eye drops
 Drug: bimatoprost eye drops
1 drop in each eye daily for 1 month
Placebo Comparator: 2
placebo
 Drug: placebo
1 drop in each eye daily for 1 month

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic glaucoma or ocular hypertension
  • IOP controlled on Xalatan

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Known hypersensitivity to study medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538304

Locations
United States, Georgia
Atlanta, Georgia, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00538304     History of Changes
Other Study ID Numbers: 192024-035
Study First Received: September 28, 2007
Results First Received: September 19, 2011
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Bimatoprost
Nasal Decongestants
Vasoconstrictor Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013