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Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00541242
First received: October 5, 2007
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension


Condition Intervention Phase
Ocular Hypertension
Glaucoma
 Drug: bimatoprost 0.03% eye drops
Drug: latanoprost 0.005% eye drops
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Diurnal Intraocular Pressure (IOP) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. 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.

  • Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]
    Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. 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.


Enrollment: 586
Study Start Date: December 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
bimatoprost 0.03% eye drops
 Drug: bimatoprost 0.03% eye drops
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
Other Names:
  • latanoprost = Xalatan®
  • bimatoprost = Lumigan®
Active Comparator: 2
latanoprost 0.005% eye drops
 Drug: latanoprost 0.005% eye drops
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
Other Name: Xalatan®

  Eligibility

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

Inclusion Criteria:

  • Ocular hypertension or chronic glaucoma
  • Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Hypersensitivity to study medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541242

Locations
United States, California
Newport Beach, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00541242     History of Changes
Other Study ID Numbers: 192024-034
Study First Received: October 5, 2007
Results First Received: September 19, 2011
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Tetrahydrozoline
Latanoprost
Bimatoprost
Cloprostenol
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
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013