PLATELET CONCENTRATE for Dry Eye Disease

Inclusion criteria

• {"criterion_text":"- Patients aged at least 18 years\n- Patients with a history of self-reported DED symptoms for a minimum period of 3 months, supported by a clinical diagnosis of DED at the time of the screening visit, with the following items being met, in at least one eye: a. Tear film break-up time ≤ 10 seconds. b. Ocular surface staining > 1 on Oxford scale.\n- OSDI test ≥ 23.\n- Patients who have previously signed informed consent.\n- Willingness to perform all study visits and procedures."}

Exclusion criteria

• {"criterion_text":"- Ocular conditions/diseases 1.\tAny ocular abnormality other than EOS that interferes with the ocular surface including: trauma, post-radiation keratitis, infectious keratitis, Stevens-Johnson syndrome, graft-versus-host disease, ocular herpes, dacryocystitis, etc. As well as known chronic diseases that clinically compromise visual function: glaucoma, macular degeneration, proliferative diabetic retinopathy, and clinically significant primary or secondary cataracts. 2.\tPatients in whom the implantation of punctal plugs is anticipated during the study should be excluded. However, patients with punctal plugs placed before (> 1 month) the screening visit are eligible for enrollment; however, the plugs must remain in place during the course of the study. 3.\tActive non-infectious ocular inflammation (e.g., uveitis, scleritis, peripheral ulcerative keratitis) at the time of screening. 4.\tAny ocular disease other than EOS requiring chronic topical ocular treatment during the course of the study. 5.\tHistory of severe systemic allergy or ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis/keratitis other than that associated with dry eye. 6.\tUse of contact lenses, nasal stimulation device (True Tear®), moisture goggles and/or amniotic membrane without sutures, during the study (prior use is not an exclusion criterion, but must be discontinued at the screening visit). 7.\tAny prior ocular surgery (including refractive surgery, keratoplasties, palpebral, cataract, conjunctival surgeries, corneal transplantation), if performed within 90 days prior to the screening visit. These procedures are not allowed during the course of the study. 8.\tAbnormal eyelid anatomy, abnormalities in the nasolacrimal drainage system or blink dysfunction in either eye affecting palpebral function. 9.\tConjunctival disorders affecting tear stability, e.g. conjunctival neoplasms.\n- Ocular treatments 10.\tUse of topical anti-inflammatory medication such as topical corticosteroids, lifitegrast, cyclosporine (e.g. Restasis®, Ikervis®, magistral formula), tacrolimus, NSAIDs, in either eye during the study (prior use is not an exclusion criterion, but these treatments should be discontinued during the course of the study). 11.\tUse of autologous serum or other hematic derivatives in either eye during the course of the study (prior use is not an exclusion criterion, but this treatment must be discontinued during the course of the study). 12.\tUse of any type of artificial tears other than those provided by the study sponsor during the course of the study.\n- Systemic conditions/diseases or treatments 13.\tPresence of blood disorders related to platelet or coagulation alterations. 14.\tPatients with uncontrolled autoimmune diseases at the time of the screening visit in the study, or patients with active systemic infectious processes. Patients positive for blood-borne infectious diseases (HBV, HCV, HIV, syphilis, etc.). 15.\tAny changes within 30 days after the screening visit, or any anticipated changes during the course of the study, in the dosage of systemic medications that could worsen dry eye [e.g., estrogen-progesterone or other estrogen derivatives (postmenopausal women only), pilocarpine, isotretinoin, tetracycline, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, phenothiazines, omega-3, systemic corticosteroids, systemic immunosuppressants, etc]. These treatments are allowed during the study, provided they remain stable during the course of the study. 16.\tIllness not stabilized within 30 days prior to the screening visit (e.g., diabetes with out-of-range blood glucose, thyroid malfunction, uncontrolled autoimmune disease, active systemic infections) or any that, in the investigator's judgment, is incompatible with the study. 17.\tPresence or history of severe systemic allergy. 18.\tKnown hypersensitivity to any of the components of the study drugs or used in the procedures (e.g., fluorescein, lissamine green, etc.). 19.\tHistory of uncontrolled neoplastic disease within the last 5 years. 20.\tPregnancy or breastfeeding at the initial visit. 21.\tWomen of childbearing age who are not taking effective contraceptive measures, as outlined in the CTFG \"Recommendations Regarding Contraception and Pregnancy Testing in Clinical Trials\" V 1.1, throughout the conduct of the study treatment periods and up to 2 weeks after the study. Postmenopausal women (two years without menstruation) do not need to use any method of birth control. 22.\tHistory or presence of general systemic condition or serious ocular condition that the investigator determines may confound study results or increase risk to the patient.\n- Compliance/administrative 23.\tHistory of drug addiction or alcohol abuse (more than 4 standard drinks per day) within the past 2 years. 24.\tPresence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the performance of the required study procedures or the interpretation of study results. 25.\tParticipation in a clinical trial with an investigational product within the last 30 days. 26.\tParticipation in another clinical trial at the same time as the present study."}

Primary endpoints

• {"endpoint_text":"- Efficacy: -\tSubjective evolution of patients' symptomatology using the OSDI questionnaire at 12 weeks. -\tChange in ocular surface staining at 12 weeks using the Oxford scale.","definition_or_measurement_approach":"OSDI questionnaire score at 12 weeks; ocular surface staining assessed using the Oxford scale at 12 weeks."}
• {"endpoint_text":"- Safety: •\tGlobal tolerance assessed by the investigator at 2 and 12 weeks. •\tPatient-assessed global tolerance at 2 and 12 weeks. •\tAdverse events mentioned throughout the study, both ocular and systemic. •\tOcular adverse events (AEs). •\t- Systemic adverse events (AEs)","definition_or_measurement_approach":"Investigator-assessed and patient-assessed global tolerance at weeks 2 and 12; collection and reporting of ocular and systemic adverse events throughout the study."}

Secondary endpoints

• {"endpoint_text":"- Demographic variables -\tPatient code -\tAge -\tSex -\tToxic habits (smoking, alcohol)","definition_or_measurement_approach":"Collection of demographic and identification variables (patient code, age, sex, smoking and alcohol habits)."}
• {"endpoint_text":"- Clinical variables -\tDiagnosed with Sjögren's disease (primary or secondary) -\tDiagnosed with Rosacea -\tPersonal and ophthalmologic history -\tPrevious medication","definition_or_measurement_approach":"Recording of medical history including diagnoses (Sjögren's, Rosacea), ophthalmologic history and prior medications."}
• {"endpoint_text":"- Efficacy: -\tSubjective evolution of patients' symptomatology using the OSDI questionnaire at 2 weeks. -\tChange in ocular surface staining at 2 weeks using the Oxford scale. -\tChange in global pathology symptoms with respect to severity and frequency at 2 and 12 weeks using the Visual Analog Scale (VAS). -\tChange in best corrected visual acuity (LogMAR VA) at 2 and 12 weeks.","definition_or_measurement_approach":"OSDI at 2 weeks; Oxford scale staining at 2 weeks; VAS for severity/frequency at weeks 2 and 12; LogMAR visual acuity at weeks 2 and 12."}
• {"endpoint_text":"- Efficacy: -\tChange in tear quantity at 2 and 12 weeks using Schirmer's test. -\tChange in time to tear film breakage (TBUT) at 2 and 12 weeks. -\tIntraocular pressure (IOP) at 2 and 12 weeks.","definition_or_measurement_approach":"Schirmer's test for tear quantity, TBUT measurement for tear film break-up time, and intraocular pressure measurements at weeks 2 and 12."}

Spain

Earliest CTIS Part Ii Submission Date

26-02-2025

Latest Decision Or Authorization Date

23-07-2025

Processing Time Days

147

Number Of Sites

1

Number Of Participants

54

Primary sponsor

Full Name

Biotechnology Institue I Mas D S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain