Study to evaluate the regenerative efficacy of Endoret® (PRGF-Plasm Rich in Growth Factors) on the ocular surface of glaucoma patients treated chronically with ocular hypotensive drugs

Phase 1

• Conditions: Glaucoma; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2019-001647-46-ES
• Lead Sponsor: Institut de Recerca H. de la Santa Creu i Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients of legal age and diagnosed with glaucoma who are in treatment with at least two ocular hypotensive drugs (3 drops / day) without preservatives for at least the last two years and who consent to participate in the study.
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pathology of the ocular surface other than toxicity by hypotensive drugs; previous ocular surface surgeries; treatments with topical blood products in the last 6 months, women of childbearing age with gestational desire, pregnant and lactating; serious adverse events during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified