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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716742
• Other study ID #: Pro2
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: November 30, 2011
• Start date: September 2004
• Est. completion date: September 2009

Study information

• Verified date: November 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1099
• Est. completion date: September 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%
1 drop in eye(s) every evening

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Bilateral Intraocular Pressure (IOP) at One 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).	Baseline, 1 Year	No