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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Bimatoprost
Latanoprost
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014