Randomized, double-blind, parallel group clinical trial to evaluate the efficacy and safety of PRGF eye drops as a treatment for dry eye disease in patients with glaucoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biotechnology Institute I Mas D S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

8 Nov 2022 → ongoing

Decision date (initial)

2024-11-28

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-519460-40-00

EudraCT number

2022-001662-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of PRGF eye drops in relieving dry eye symptomatology in glaucoma patients.

Secondary objectives 1

1. To determine the safety profile of PRGF eye drops in the treatment of dry eye disease in glaucoma patients.

Conditions and MedDRA coding

Glaucoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Signed and dated informed consent. 2. Man or woman over 50 years of age. 3. Controlled glaucoma or ocular hypertension (OHT) requiring pharmacological treatment with at least one active ingredient with preservatives and presenting ocular dryness. 4. The patient must have discontinued treatment with artificial tears at least one week prior to this visit. 5. Diagnosis of moderate to severe dry eye syndrome defined by OSDI score ≥ 13. 6. Patient who has at least one eye that meets the following requirements: - Total ocular staining (cornea and conjunctiva) with Oxford scale grade between grade 2 to 5. - At least one of the following objective signs: o Schirmer's test ≥ 3 mm/5 min and ≤ 9 mm/5 min, o TBUT: <10 seconds. 7. Patients with glaucoma: optic nerve involvement compatible with this disease (focal or diffuse thinning of the neuroretinal ring), objectified by previous optical coherence tomography (OCT), independent of whether they have campimetric defect and IOP figure. 8. Patients with OHT: IOP > 21 mmHg in at least two measurements, without optic nerve involvement, requiring ocular hypotensive treatment. 9. Absence of progression of OHT or glaucoma in the year prior to the start of the study, objectifiable by OCT and/or campimetry.

Exclusion criteria 4

1. Exclusion criteria of ophthalmic nature in at least one eye 1. Ocular rosacea 2. History of ocular trauma or ocular infection in the previous 3 months. 3. History of ocular allergy 4. History of uveitis (last episode less than 6 months). 5. History of inflammatory corneal ulcer in the last 12 months. 6. Ocular surgery in the previous 3 months or foreseen indication for ocular surgery during the duration of the study.
2. Systemic/non-ophthalmic exclusion criteria 7. Known or suspected hypersensitivity to one of the components of the investigational product or ancillary products. 8. History of any active systemic condition incompatible with the investigation or which, in the investigator's judgment, may interfere with the results of the investigation or with patient safety 9. Active allergic rhinitis or allergic rhinitis likely to reactivate during the investigation. 10. Any other medical or surgical history, disorder or disease likely to require or modify systemic medication during the investigation (systemic medication must be stable in the three months prior to screening).
3. Exclusion criteria specifically related to women of childbearing potential 11. Pregnancy or breastfeeding 12. Women of childbearing age who are not using reliable contraceptive methods (oral contraceptives, IUD, subdermal contraceptive implants, vaginal ring, patch) and who have not undergone surgical sterilization.
4. Exclusion criteria relating to factors of a general nature 13. Inability of the patient to understand the research procedures or to give informed consent. 14. Non-compliance on the part of the patient (e.g., refusal to attend a visit or to complete a questionnaire or study tests); 15. Participation in this trial at the same time as participation in another trial. 16. Participation in this trial during the opt-out period of another trial; 17. 17. Patients who are institutionalized by court or regulatory order, who are confined in psychiatric facilities, correctional institutions, or state institutions, and employees of the sponsor's research facilities or company. 18. Patient not covered by the public health system. 19. Patient under guardianship or court-ordered guardianship. 20. Patients who have used or use a prohibited treatment (or perform a prohibited modification of the therapeutic regimen). 21. Patients diagnosed with coagulopathies or autoimmune diseases, infection or tumor in the area of application, or retinopathy. 22. Patients with hepatic insufficiency.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Change in the degree of ocular staining at 6 months using the Oxford scale. - Evolution of symptomatology at 6 months according to the Ocular Surface Disease Index (OSDI).

Secondary endpoints 9

1. - Change in the degree of ocular staining at 3 months using the Oxford scale.
2. Change in symptomatology at 3 months according to the Ocular Surface Disease Index (OSDI).
3. Change in the amount of tears produced at 3 and 6 months using the Schirmer test.
4. Change in tear breakup time (TBUT) at 3 and 6 months.
5. - Evolution of conjunctival hyperemia at 3 and 6 months using the McMonnies photographic scale.
6. - Evolution of corrected distance visual acuity in both eyes at 3 and 6 months.
7. - Change in the concentration of inflammation biomarkers S100A8 and MMP-9 in tears at 3 and 6 months post-treatment.
8. Demographic and identification variables - Patient code - Age - Sex - Toxic habits (alcohol, tobacco)
9. Safety variables - Global tolerance assessed by the investigator at 3 and 6 months. - Patient-assessed global tolerance at 3 and 6 months. - Type and frequency of ocular adverse events. - Type and frequency of systemic adverse events.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biotechnology Institute I Mas D S.L.

Sponsor organisation

Biotechnology Institute I Mas D S.L.

Address

Calle De San Antonio 15 5a

City

Vitoria

Postcode

01005

Country

Spain

Scientific contact point

Organisation

Biotechnology Institute I Mas D S.L.

Contact name

Mohammad Alkhraisat Almasoud

Public contact point

Organisation

Biotechnology Institute I Mas D S.L.

Contact name

Mohammad Alkhraisat Almasoud

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications