We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00716742
First Posted: July 16, 2008
Last Update Posted: January 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716742


Locations
United States, Tennessee
Murfreesboro, Tennessee, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00716742     History of Changes
Other Study ID Numbers: Pro2
First Submitted: July 14, 2008
First Posted: July 16, 2008
Results First Submitted: November 30, 2011
Results First Posted: January 6, 2012
Last Update Posted: January 6, 2012
Last Verified: November 2011

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Latanoprost
Bimatoprost
Travoprost
Antihypertensive Agents