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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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