Overview

Brimonidine vs ALTP in Progressing Human Glaucoma

Status:
Completed
Trial end date:
2002-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Parma
Treatments:
Brimonidine Tartrate
Criteria
Inclusion Criteria:

- Glaucomatous visual field defect on achromatic perimetry (24/2 Humphrey full
threshold,abnormal GHT and CPSD, p<0.01) considered clinically "unstable"

- IOP < 20 mmHg on repeated readings with no more than 2 medications,

- Open angle on gonioscopy,

- Glaucomatous optic neuropathy (HRTII, Moorfields regression analysis),

- Clear lens (LOCS2 score < C1, N0, P0)

- Best corrected visual acuity better than 0.2 LogMAR (ETDRS chart),

- No previous bulbar surgery

- Manifest refraction within - 5 and + 2 diopters

- No comorbidity (AMD and diabetic retinopathy.and negative history for neurological
diseases)

Exclusion Criteria:

- Closed angle

- Previous bulbar surgery

- Unstable IOP

- Unreliable visual fields on historic data