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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00716742
First received: July 14, 2008
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  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%

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year [ Time Frame: Baseline, 1 Year ] [ Designated as safety issue: No ]
    Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).


Enrollment: 1099
Study Start Date: September 2004
Study Completion Date: September 2009
Primary Completion Date: September 2007 (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
Other Names:
  • Lumigan®
  • Xalatan®
  • Travatan®

  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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00716742     History of Changes
Other Study ID Numbers: Pro2
Study First Received: July 14, 2008
Results First Received: November 30, 2011
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
 Latanoprost
Travoprost
Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013