NCT00466479

Brimonidine vs ALTP in Progressing Human Glaucoma

Topical Brimonidine vs Argon Laser Trabeculoplasty in Progressing Human Glaucoma. A Prospective Randomized Clinical Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: University of Parma · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating possible non-intraocular pressure (IOP) related effects of the alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.

Detailed description

Patients with open angle glaucoma and a history of relative stability of the visual field are followed for 18 months. A visual field is measured every 3 months for a total number of n = 6 eligible fields at the end of this phase. Then, those eyes showing progression of the field (i.e. deterioration of th eexisting glaucoma), are randomized to receive either 0.2% brimonidine tartrate eyedrops b.i.d. or 360° argon laser trabeculoplasty in one session. Either treatment will be put "on top" of the pre-existing anti-glaucoma therapy. Then, a further 18-month phase is planned, with a sequnece of field taken at the same pace as the previous phase. Progression is detected (and measured) acording to a trend-analysis (i.e. regression vs time of single points and of clusters of adjacent points).

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	brimonidine
PROCEDURE	laser trabeculoplasty

Timeline

• Start date: 1999-08-01
• Completion: 2002-10-01
• First posted: 2007-04-27
• Last updated: 2007-04-27

Locations

1 site across 1 country: Italy