Frontlight ResearchEarly access
Taking people in SpainPhase 4
Tests plasma eye drops for dry eye in people with glaucoma
Tests PRGF eye drops against dry eye symptoms in adults with glaucoma.
Key facts
- Who runs it
- Biotechnology Institute I Mas D S.L.
- Where
- Donostia, SpainSee the site
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 70 people, planned
- Started
- 8 Nov 2022
- Planned end
- 1 Sept 2025
- Type of study
- Interventional
- Record updated
- 28 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. 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
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in Spain
- Hospital Universitario DonostiaDonostia, SpainTaking people
About the trial
What the trial wants to find out
To evaluate the efficacy of PRGF eye drops in relieving dry eye symptomatology in glaucoma patients.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests plasma eye drops for dry eye in people with glaucomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 November 2024