Authorised Phase III and phase IV (Integrated) Glaucoma

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

EU CTIS ID: 2024-519460-40-00

What this study is testing

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

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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.
  • 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).
  • 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.
  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.