Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-Angle Glaucoma (OAG) - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00716742

Purpose

To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.

Condition	Intervention
Open-Angle Glaucoma Ocular Hypertension	Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost Travoprost Bimatoprost

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Allergan:

Primary Outcome Measures:

Effectiveness of IOP-lowering therapies as assessed by IOP measurements, VFD, and corneal thickness [ Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life and Patient-Reported Outcomes [ Time Frame: Assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	September 2004
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 bimatoprost 0.03% latanoprost 0.005% travoprost 0.004%	Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004% 1 drop in eye(s) every evening

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients can be either: (a) newly diagnosed and require, in the judgment of the treating physician, one of study agents as first-line treatment, (b) have an insufficiently controlled IOP on their current medication (any but not more than two in combination), and a treatment switch to one of study agents is an acceptable option.

Criteria

Inclusion Criteria:

A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
Patient is having both eyes treated

Exclusion Criteria:

Contraindications per product labelling will apply.
Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00716742

Locations

United States, Tennessee

Murfreesboro, Tennessee, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	Pro2
Study First Received:	July 14, 2008
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00716742
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Bimatoprost
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Latanoprost
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009