Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
30
Countries
1
Sites
1
glaucoma
To assess the changes in tear osmolarity after topical treatment with PRGF.
Key facts
- Sponsor
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520642-29-00
- EudraCT number
- 2019-001647-46
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the changes in tear osmolarity after topical treatment with PRGF.
Secondary objectives 4
- To evaluate the clinical and conjunctival cytological changes after topical treatment with PRGF.
- To assess the clinical and biochemical changes in the tear film after topical treatment with PRGF.
- To evaluate the symptomatic changes perceived by the patient after topical treatment with PRGF and the impact on their quality of life.
- To assess the safety of topical PRGF treatment in glaucoma patients undergoing treatment with ocular hypotensive drugs.
Conditions and MedDRA coding
glaucoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult patients diagnosed with glaucoma who are undergoing treatment with at least two ocular hypotensive drugs (3 drops/day) without preservatives for a minimum of the last two years and who consent to participate in the study.
Exclusion criteria 5
- Ocular surface pathology other than toxicity due to ocular hypotensive drugs.
- Previous ocular surface surgeries.
- Treatment with topical blood derivatives in the last 6 months.
- Women of childbearing age with pregnancy intention, pregnant women, and breastfeeding women.
- Allergy to local anesthetics.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Tear Osmolarity: It will be measured using the Tearlab® system (a painless collection of a 30-nanoliter tear sample using a microchip with immediate results). The difference in tear osmolarity between V0 and V2 will be evaluated. Tear osmolarity has been selected as the primary variable of the study because its increase (hyperosmolarity) has been shown to be the best standalone clinical sign for diagnosing ocular surface pathology.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11962177 · Product
- Active substance
- Fibrin Matrix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 1 U unit(s)
- Max total dose
- 1 U unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- S01KX — OTHER SURGICAL AIDS
- MA holder
- FUNDACIO INSTITUT DE RECERCA DE L HOSPITAL DE LA SANTA CREU I SANT PAU
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Sponsor organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Address
- Calle Sant Quinti 77-79
- City
- Barcelona
- Postcode
- 08041
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Public contact point
- Organisation
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Contact name
- Alejandra Espinosa
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-520642-29-00 pub | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements pub | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pub | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Spain | Acceptable with conditions 2025-01-29
|
2025-01-29 |