2024-519460-40-00RecruitingPhase 4
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy of PRGF eye drops in relieving dry eye symptomatology in glaucoma patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 13 Nov 2024
- Start date
- 8 Nov 2022
- Lead sponsor
- Biotechnology Institute I Mas D S.L.
- Diseases
- Glaucoma
- EU CT number
- 2024-519460-40-00
- EudraCT number
- 2022-001662-35
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 70
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people over 50 with controlled glaucoma or raised eye pressure who also have moderate to severe dry eye. It tests PRGF eye drops.
- Age
- Over 50 years
- Sex
- Men and women
- Disease stage
- Controlled glaucoma or ocular hypertension (high eye pressure) that needs drug treatment with at least one preserved eye drop, with no worsening in the past year. Moderate to severe dry eye (OSDI score of 13 or more) with eye surface staining grade 2 to 5 and a low Schirmer's test or short tear break-up time in at least one eye.
- Earlier treatment
- Must have stopped artificial tears at least one week before. Must be on stable systemic medication for the three months before screening.
- Biomarker or test result
- OSDI score of 13 or more. Schirmer's test 3 mm/5 min to 9 mm/5 min, or TBUT under 10 seconds, in at least one eye. In ocular hypertension, eye pressure above 21 mmHg on at least two measurements.
Main reasons for not taking part
- Ocular rosacea, eye allergy, or past uveitis (last episode less than 6 months ago)
- Eye injury or eye infection in the last 3 months
- Eye surgery in the last 3 months or planned during the study
- Pregnancy or breastfeeding
- Blood clotting disorders, autoimmune diseases, retinopathy, or liver failure
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Donostia | Donostia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.