Assessment of the Regenerative Efficacy of Fibrin Matrix (Endoret-PRGF) on the Ocular Surface in Glaucoma Patients Undergoing Chronic Ocular Hypotensive Therapy

The primary objective of this study is to assess the changes in **tear osmolarity** after topical treatment with Endoret® (PRGF-Plasm Rich in Growth Factors) in patients with **glaucoma** who are undergoing chronic treatment with ocular hypotensive drugs. Evaluating tear osmolarity is clinically relevant as it provides insights into the ocular surface's health and the potential regenerative effects of PRGF on tear film stability, which is crucial for maintaining ocular surface integrity in glaucoma patients.

Secondary objectives include:

• Evaluating the clinical and conjunctival cytological changes after topical treatment with PRGF.
• Assessing the clinical and biochemical changes in the tear film following PRGF treatment.
• Evaluating the symptomatic changes perceived by the patient and the impact on their quality of life after PRGF treatment.
• Assessing the safety of topical PRGF treatment in glaucoma patients undergoing treatment with ocular hypotensive drugs.

The clinical trial involves **adult patients** diagnosed with **glaucoma** who are currently undergoing treatment with at least two ocular hypotensive drugs, administered as three drops per day without preservatives, for a minimum duration of the last two years. The study population includes both male and female participants, with an age range that encompasses middle-aged to older adults. Participants were selected based on their consent to participate in the study and their adherence to the specified treatment regimen. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or other habits are not specified in the available data.

The clinical trial is designed to evaluate the regenerative efficacy of **ENDORET-PRGF**, a **solution for injection**, on the ocular surface of patients with **glaucoma** who are undergoing chronic treatment with ocular hypotensive drugs. This study is a Phase 4, randomized, double-blind, controlled trial. The primary objective is to assess changes in tear osmolarity following topical treatment with **PRGF**. The trial is expected to commence recruitment on January 22, 2025, and conclude by January 22, 2026, with an estimated duration of one year.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the principal inclusion criteria: adult patients diagnosed with **glaucoma** who have been treated with at least two ocular hypotensive drugs without preservatives for a minimum of two years. The primary endpoint, tear osmolarity, will be measured using the Tearlab® system, which involves a painless collection of a 30-nanoliter tear sample. The difference in tear osmolarity between the initial visit (V0) and the second visit (V2) will be evaluated to determine the treatment's efficacy.

The expected length of participant involvement is approximately one year, with regular follow-up visits scheduled to monitor progress and collect data. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse reactions to the treatment, or withdrawal of consent by the participant. The trial is not classified as a low-intervention study, and the product is not an orphan drug. The study is conducted under the sponsorship of the Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

The clinical trial involves the use of the experimental medication **ENDORET-PRGF**, which is a **solution for injection**. The active substance in this formulation is **fibrin matrix**, classified under the ATC code S01KX, indicating its use as an "Other Surgical Aid." The **fibrin matrix** is derived from a polymer origin. The medication is administered via injection, with a maximum daily dose of 1 unit and a total maximum dose of 1 unit over the treatment period. The treatment duration is limited to a maximum of one day. The product is not a pediatric formulation and is not classified as an orphan drug. The sponsor of this product is the Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

In this study, there are no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments mentioned. The focus is solely on evaluating the regenerative efficacy of **ENDORET-PRGF** on the ocular surface of glaucoma patients who have been treated chronically with ocular hypotensive drugs. The main objective is to assess changes in tear osmolarity following the topical application of **PRGF**. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the treatment protocol.

The clinical trial aims to evaluate the regenerative efficacy of Endoret® (PRGF-Plasma Rich in Growth Factors) on the ocular surface of patients with glaucoma who are chronically treated with ocular hypotensive drugs. The primary endpoint for assessing efficacy is the change in **tear osmolarity**. This parameter will be measured using the Tearlab® system, which involves a painless collection of a 30-nanoliter tear sample using a microchip, providing immediate results. The difference in tear osmolarity will be evaluated between baseline (V0) and a subsequent visit (V2). Tear osmolarity has been chosen as the primary variable due to its established role as a standalone clinical sign for diagnosing ocular surface pathology. The trial is designed to assess the changes in tear osmolarity after topical treatment with PRGF, with the primary objective being to determine the efficacy of the treatment in improving ocular surface conditions in the specified patient population.