glaucoma MedDRA version: 9.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension
Conditions
Interventions
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 135-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo:
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA IN OHT PATIENTS 61623; IOP 21 mm Hg in two separate occasions at diagnosis. 61623; IOP steady at least in the last three months. 61623; Optic nerve head with normal morphology in stereoscopic evaluation performed with biomicroscopy and 78D lens. 61623; Standard automated perimetry Humphrey 30-2 SITA Standard test within normal limits. 61623; Alteration of PERG. 61623; Familiarity for glaucoma INCLUSION CRITERIA IN EOAG PATIENT 61623; IOP 21 mm Hg in two separate occasions at diagnosis. 61623; IOP steady at least in the last three months. 61623; Optic nerve head with normal morphology in stereoscopic evaluation performed with biomicroscopy and 78D lens. 61623; Standard automated perimetry Humphrey 30-2 SITA Standard test out of normal limits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 61623; Therapy change. 61623; Smokers. 61623; Antecedent ocular surgeries. 61623; Concomitant ocular or systemic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study evaluates the effects of this molecule epigallocatechin-gallate on the retinal ganglion cells, in glaucomatous patients, using pattern electroretinogram PERG and Optical Coherence Tomography OCT .;Secondary Objective: nd;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed