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

September 28, 2007
September 19, 2011
November 2007
May 2008   (final data collection date for primary outcome measure)
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.
Conjunctival hyperemia; IOP
Complete list of historical versions of study NCT00538304 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Not Provided

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: bimatoprost eye drops
    1 drop in each eye daily for 1 month
  • Drug: placebo
    1 drop in each eye daily for 1 month
  • Experimental: 1
    bimatoprost eye drops
    Intervention: Drug: bimatoprost eye drops
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic glaucoma or ocular hypertension
  • IOP controlled on Xalatan

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Known hypersensitivity to study medications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00538304
192024-035
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP