Efficacy and Safety Evaluation of Plasma Rich in Growth Factors Eye Drops for Dry Eye Disease in Glaucoma Patients: A Randomized, Double-Blind, Parallel Group Study

Trial ID: 2024-519460-40-00
Sponsor: Biotechnology Institute I Mas D S.L.

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Diseases & Conditions

Glaucoma Dry eye

Objectives

The primary objective of this randomized, double-blind, parallel group clinical trial is to evaluate the **efficacy** of Plasma Rich in Growth Factors (PRGF) eye drops in alleviating symptoms of **dry eye disease** in patients with **glaucoma**. This is clinically relevant as dry eye disease is a common comorbidity in glaucoma patients, often exacerbated by the use of intraocular pressure-lowering medications, and can significantly impact the quality of life and treatment adherence.

Secondary objectives include determining the **safety profile** of PRGF eye drops in the treatment of dry eye disease in glaucoma patients. Understanding the safety profile is crucial for ensuring that the treatment does not introduce adverse effects that could compromise patient safety or treatment outcomes.

Participants

The clinical trial focuses on evaluating the efficacy of PRGF eye drops in relieving **dry eye disease** symptomatology in patients with **glaucoma**. The study population includes both male and female participants over the age of 50, with a specific focus on individuals diagnosed with controlled glaucoma or ocular hypertension requiring pharmacological treatment. Participants must present with ocular dryness and have discontinued treatment with artificial tears at least one week prior to the study. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Key lifestyle considerations include the requirement for participants to have moderate to severe dry eye syndrome, as defined by an OSDI score of 13 or higher, and specific ocular conditions such as total ocular staining with an Oxford scale grade between 2 to 5. The trial population was selected based on these criteria, ensuring that participants have either optic nerve involvement compatible with glaucoma or ocular hypertension with intraocular pressure greater than 21 mmHg, without optic nerve involvement, and requiring ocular hypotensive treatment. The absence of progression of ocular hypertension or glaucoma in the year prior to the study is also a consideration for inclusion.

Plans and Procedures

The clinical trial is designed as a **randomized, double-blind, parallel group** study to evaluate the efficacy and safety of **Plasma rich in growth factors** (PRGF) eye drops in treating **dry eye disease** in patients with **glaucoma**. The trial will involve two groups: one receiving the PRGF eye drops and the other receiving a **preservative-free eye drop formulation** as a comparator. The study will be conducted over a period of approximately 34 months, with an estimated recruitment start date of November 8, 2022, and an estimated end date of September 1, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age, controlled glaucoma or ocular hypertension, and a diagnosis of moderate to severe dry eye syndrome. Following the screening, eligible participants will be randomized into one of the two treatment groups. The primary endpoint will be assessed at 6 months, focusing on changes in ocular staining and symptomatology using the Oxford scale and the Ocular Surface Disease Index (OSDI), respectively. Secondary endpoints will include changes in ocular staining, symptomatology, tear production, tear breakup time, conjunctival hyperemia, visual acuity, and inflammation biomarkers at 3 and 6 months.

Participants are expected to be involved in the study for a maximum treatment period of 12 months, with follow-up visits scheduled at 3 and 6 months to monitor efficacy and safety outcomes. The study will also evaluate safety variables, including global tolerance and the frequency of ocular and systemic adverse events. Conditions that may lead to early termination from the study include significant adverse events or progression of ocular conditions that compromise participant safety. The trial is categorized as a low intervention study, ensuring minimal risk to participants while providing valuable insights into the treatment of dry eye disease in glaucoma patients.

Treatment

The clinical trial involves the use of **Plasma rich in growth factors** as the experimental medication. This product is formulated as **eye drops** and contains the active substance **platelet concentrate**, also known as **platelet rich plasma human**. The eye drops are intended for **ophthalmic use** and are administered at a maximum daily dose of 0.4 ml, with a total maximum dose of 33.6 ml over a treatment period of 12 weeks. The product is derived from a structurally diverse blood-derived substance and is manufactured by Biotechnology Institute I Mas D S.L. Participant compliance with the dosing schedule will be monitored throughout the trial.

The comparator treatment in this study is a **preservative-free eye drop formulation**. This formulation is also administered for **ophthalmic use** with a maximum daily dose of 0.4 ml and a total maximum dose of 33.6 ml over the same 12-week treatment period. The comparator serves as a standard-of-care therapy to evaluate the efficacy and safety of the experimental medication. The preservative-free nature of the comparator ensures that it does not interfere with the assessment of the experimental treatment's effects on dry eye disease in patients with glaucoma.

Efficacy

The efficacy of Plasma Rich in Growth Factors (PRGF) eye drops in treating dry eye disease in patients with glaucoma will be assessed through a randomized, double-blind, parallel group clinical trial. The primary endpoints for evaluating efficacy include the change in the degree of ocular staining at 6 months using the Oxford scale and the evolution of symptomatology at 6 months according to the Ocular Surface Disease Index (OSDI). Secondary endpoints will be measured at 3 and 6 months and include changes in ocular staining, symptomatology, tear production using the Schirmer test, tear breakup time (TBUT), conjunctival hyperemia using the McMonnies photographic scale, corrected distance visual acuity, and the concentration of inflammation biomarkers S100A8 and MMP-9 in tears.

Data collection will occur at specified intervals, with assessments conducted at 3 and 6 months post-treatment. The Oxford scale will be utilized to quantify ocular staining, while the OSDI will be employed to evaluate symptomatology. The Schirmer test will measure tear production, and TBUT will assess tear film stability. Conjunctival hyperemia will be evaluated using the McMonnies photographic scale, and visual acuity will be measured for both eyes. Biomarker concentrations will be analyzed to assess inflammation levels. Safety and tolerance will also be monitored, with both investigator and patient assessments of global tolerance, as well as documentation of ocular and systemic adverse events.

Inclusion and Exclusion Criteria

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Inclusion Criteria

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.

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Exclusion Criteria

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.