Randomized clinical trial to evaluate the use of PRGF eye drops in patients with dry eye disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biotechnology Institue I Mas D S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2024-08-26

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The main objective of Part A of the study is to evaluate the safety of PRGF eye drops administered four times daily, and for 12 weeks of treatment, in patients with dry eye disease.
The main objective of Part B of the study is to evaluate the superiority of PRGF eye drops administered four times daily, and for 12 weeks of treatment, in patients with dry eye disease, versus treatment with artificial tear eye drops (0.3% hypromellose).

Conditions and MedDRA coding

Dry Eye Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients aged at least 18 years
2. 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.
3. OSDI test ≥ 23.
4. Patients who have previously signed informed consent.
5. Willingness to perform all study visits and procedures.

Exclusion criteria 4

1. Ocular conditions/diseases 1. Any 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. Patients 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. Active non-infectious ocular inflammation (e.g., uveitis, scleritis, peripheral ulcerative keratitis) at the time of screening. 4. Any ocular disease other than EOS requiring chronic topical ocular treatment during the course of the study. 5. History of severe systemic allergy or ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis/keratitis other than that associated with dry eye. 6. Use 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. Any 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. Abnormal eyelid anatomy, abnormalities in the nasolacrimal drainage system or blink dysfunction in either eye affecting palpebral function. 9. Conjunctival disorders affecting tear stability, e.g. conjunctival neoplasms.
2. Ocular treatments 10. Use 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. Use 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. Use of any type of artificial tears other than those provided by the study sponsor during the course of the study.
3. Systemic conditions/diseases or treatments 13. Presence of blood disorders related to platelet or coagulation alterations. 14. Patients 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. Any 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. Illness 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. Presence or history of severe systemic allergy. 18. Known hypersensitivity to any of the components of the study drugs or used in the procedures (e.g., fluorescein, lissamine green, etc.). 19. History of uncontrolled neoplastic disease within the last 5 years. 20. Pregnancy or breastfeeding at the initial visit. 21. Women 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. History or presence of general systemic condition or serious ocular condition that the investigator determines may confound study results or increase risk to the patient.
4. Compliance/administrative 23. History of drug addiction or alcohol abuse (more than 4 standard drinks per day) within the past 2 years. 24. Presence 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. Participation in a clinical trial with an investigational product within the last 30 days. 26. Participation in another clinical trial at the same time as the present study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Efficacy: - Subjective evolution of patients' symptomatology using the OSDI questionnaire at 12 weeks. - Change in ocular surface staining at 12 weeks using the Oxford scale.
2. Safety: • Global tolerance assessed by the investigator at 2 and 12 weeks. • Patient-assessed global tolerance at 2 and 12 weeks. • Adverse events mentioned throughout the study, both ocular and systemic. • Ocular adverse events (AEs). • - Systemic adverse events (AEs)

Secondary endpoints 4

1. Demographic variables - Patient code - Age - Sex - Toxic habits (smoking, alcohol)
2. Clinical variables - Diagnosed with Sjögren's disease (primary or secondary) - Diagnosed with Rosacea - Personal and ophthalmologic history - Previous medication
3. Efficacy: - Subjective evolution of patients' symptomatology using the OSDI questionnaire at 2 weeks. - Change in ocular surface staining at 2 weeks using the Oxford scale. - Change in global pathology symptoms with respect to severity and frequency at 2 and 12 weeks using the Visual Analog Scale (VAS). - Change in best corrected visual acuity (LogMAR VA) at 2 and 12 weeks.
4. Efficacy: - Change in tear quantity at 2 and 12 weeks using Schirmer's test. - Change in time to tear film breakage (TBUT) at 2 and 12 weeks. - Intraocular pressure (IOP) at 2 and 12 weeks.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biotechnology Institue I Mas D S.L.

Sponsor organisation

Biotechnology Institue I Mas D S.L.

Address

Calle San Antonio 15 5a

City

Vitoria-Gasteiz

Postcode

01015

Country

Spain

Scientific contact point

Organisation

Biotechnology Institue I Mas D S.L.

Contact name

Aitana Sainz

Public contact point

Organisation

Biotechnology Institue I Mas D S.L.

Contact name

Aitana Sainz

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications