Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00541242

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 IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost Tetrahydrozoline Tetrahydrozoline hydrochloride Bimatoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

IOP [ Time Frame: Week 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: Day 1 - Week 18 ] [ Designated as safety issue: No ]

Enrollment:	587
Study Start Date:	December 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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
2: Active Comparator	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

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

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	192024-034
Study First Received:	October 5, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00541242
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pseudoephedrine
Bimatoprost
Eye Diseases
Vascular Diseases
Tetrahydrozoline
Latanoprost
Cloprostenol
Naphazoline

Oxymetazoline
Guaifenesin
Glaucoma
Phenylephrine
Ephedrine
Phenylpropanolamine
Ocular Hypertension
Hypertension

Additional relevant MeSH terms:

Respiratory System Agents
Contraceptive Agents
Sympathomimetics
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Cardiovascular Agents
Antihypertensive Agents

Luteolytic Agents
Pharmacologic Actions
Nasal Decongestants
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009