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

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. Identifier: NCT00716742
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : January 6, 2012
Last Update Posted : January 6, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment
Open-Angle Glaucoma Ocular Hypertension Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%

Study Type : Observational
Actual Enrollment : 1099 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2009

Group/Cohort Intervention/treatment
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®

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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.

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 identifier (NCT number): NCT00716742

United States, Tennessee
Murfreesboro, Tennessee, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan

Responsible Party: Allergan Identifier: NCT00716742     History of Changes
Other Study ID Numbers: Pro2
First Posted: July 16, 2008    Key Record Dates
Results First Posted: January 6, 2012
Last Update Posted: January 6, 2012
Last Verified: November 2011

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