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

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001647-46-ES

Enrollment

Registered

2019-11-11

Start date

2020-01-20

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Interventions

Product Name: PRP Pharmaceutical Form: Eye drops INN or Proposed INN: Platelet Rich Plasma (PRP) Other descriptive name: AUTOLOGOUS PLASMA

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Tear osmolarity;Timepoint(s) of evaluation of this end point: Two and four months after the start of treatment; Main Objective: General objective: To evaluate the changes produced, both clinically and biochemically and cytologically, by the topical treatment with PRGF on the ocular surface in patients with glaucoma chronically exposed to ocular hypotensive drugs. Main objective:To evaluate the changes in tear osmolarity produced after topical treatment with PRGF. ; Secondary Objective: -To evaluate conjunctival clinical and cytological changes produced after topical treatment with PRGF -To evaluate the clinical and biochemical changes of the lacrimal film produced after the topical treatment of PRGF -To evaluate changes in symptomatology perceived by the patient after topical treatment with PRGF and changes in their quality of life. -To evaluate the safety of topical treatment with PGRF in patients with Glaucoma under treatment with ocular hypotensive drugs.	—

Measure

Time frame

Primary end point(s): Tear osmolarity;Timepoint(s) of evaluation of this end point: Two and four months after the start of treatment; Main Objective: General objective: To evaluate the changes produced, both clinically and biochemically and cytologically, by the topical treatment with PRGF on the ocular surface in patients with glaucoma chronically exposed to ocular hypotensive drugs. Main objective:To evaluate the changes in tear osmolarity produced after topical treatment with PRGF. ; Secondary Objective: -To evaluate conjunctival clinical and cytological changes produced after topical treatment with PRGF -To evaluate the clinical and biochemical changes of the lacrimal film produced after the topical treatment of PRGF -To evaluate changes in symptomatology perceived by the patient after topical treatment with PRGF and changes in their quality of life. -To evaluate the safety of topical treatment with PGRF in patients with Glaucoma under treatment with ocular hypotensive drugs.

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Secondary

Measure	Time frame
Secondary end point(s): -Symptoms of ocular surface pathology: It will be evaluated through the validated Ocular Surface Disease Index (OSDI ©) questionnaire. - Clinical signs of ocular surface pathology: corneo-conjunctival staining using fluorescein and evaluating according to Oxford scale, Lacrimal Tear Time (BUT) under slit lamp and fluorescein staining, measurement of lacrimal production by Schirmer test. - Cytological parameters of the conjunctiva, including the classification of Nelson and evaluating the presence and density of goblet cells. - Biochemical parameters of the tear film: The presence of proinflammatory cytokines in the tear (IFN gamma, TNF alpha, TGF beta, IL-2, IL-6, IL-17, IL-8, IL-13) will be analyzed. -Quality of life related to Vision: Validated Questionnaire National Eye Institute Visual Functioning Questionnaire-25 (VQ-25). -Adverse events. ;Timepoint(s) of evaluation of this end point: Two and four months after the start of treatment	—

Measure

Time frame

Secondary end point(s): -Symptoms of ocular surface pathology: It will be evaluated through the validated Ocular Surface Disease Index (OSDI ©) questionnaire. - Clinical signs of ocular surface pathology: corneo-conjunctival staining using fluorescein and evaluating according to Oxford scale, Lacrimal Tear Time (BUT) under slit lamp and fluorescein staining, measurement of lacrimal production by Schirmer test. - Cytological parameters of the conjunctiva, including the classification of Nelson and evaluating the presence and density of goblet cells. - Biochemical parameters of the tear film: The presence of proinflammatory cytokines in the tear (IFN gamma, TNF alpha, TGF beta, IL-2, IL-6, IL-17, IL-8, IL-13) will be analyzed. -Quality of life related to Vision: Validated Questionnaire National Eye Institute Visual Functioning Questionnaire-25 (VQ-25). -Adverse events. ;Timepoint(s) of evaluation of this end point: Two and four months after the start of treatment

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Countries

Spain

Contacts

Public ContactUICEC Sant Pau

Institut de Recerca H. Santa Creu i Sant Pau

epenag@santpau.cat+34935537635

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026