Evaluation of the Efficacy and Safety of Plasma Rich in Growth Factors Versus Hypromellose and Sodium Chloride in Patients with Dry Eye Disease
- Trial ID
- 2023-507357-15-01
- Protocol
- BTIIMD-02-EC-23-OJOS
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this randomized, parallel-group, double-blind clinical trial is to evaluate the **safety** and **efficacy** of Plasma Rich in Growth Factors (PRGF) eye drops in patients with **Dry Eye Disease**. Specifically, Part A of the study aims to assess the safety of PRGF eye drops when administered four times daily over a 12-week treatment period. This is clinically relevant as ensuring the safety of new treatments is crucial before considering their widespread use. Part B of the study seeks to determine the superiority of PRGF eye drops compared to artificial tear eye drops containing 0.3% hypromellose, also administered four times daily for 12 weeks. Establishing the superiority of PRGF eye drops could provide a more effective treatment option for patients suffering from Dry Eye Disease, potentially improving their quality of life.
Participants
The clinical trial involves participants diagnosed with **Dry Eye Disease**. The study population includes both male and female subjects aged 18 years and older. Participants are required to have a history of self-reported symptoms of dry eye disease for at least three months, confirmed by a clinical diagnosis at the screening visit. The trial does not involve a vulnerable population. The sponsor has not provided the total number of participants. Participants' general health status is not specified, but they must meet specific clinical criteria, such as a tear film break-up time of 10 seconds or less and an Ocular Surface Disease Index (OSDI) test score of 23 or higher. The selection process for the trial population is based on these clinical criteria, and participants must have signed informed consent and be willing to attend all study visits and procedures. No specific lifestyle considerations, such as diet or physical activity, are mentioned for this trial.
Plans and Procedures
The clinical trial is designed as a **randomized**, parallel-group, **double-blind** study to evaluate the efficacy and safety of **Plasma rich in growth factors** (PRGF) eye drops in patients with **dry eye disease**. The trial will compare PRGF eye drops with artificial tear eye drops containing **hypromellose**. The study is categorized as a low-intervention trial, adhering to the provisions of RD 1090/2015, and is expected to run from April 2025 to June 2027.
Participants will be involved in the study for a maximum of 12 weeks, during which they will attend several study visits. The sequence of visits includes an initial screening visit to confirm eligibility, followed by treatment visits at 2 weeks and 12 weeks, and an end-of-study visit. The primary objective is to assess the safety and efficacy of PRGF eye drops, with endpoints including changes in symptomatology using the OSDI questionnaire and ocular surface staining at 12 weeks. Safety assessments will include global tolerance evaluations and monitoring of adverse events.
Inclusion criteria require participants to be at least 18 years old, with a history of dry eye disease symptoms for at least 3 months, confirmed by clinical diagnosis. Participants must have a tear film break-up time of ≤10 seconds and ocular surface staining >1 on the Oxford scale in at least one eye. They must also score ≥23 on the OSDI test and provide informed consent. Exclusion criteria are not specified in the provided data.
Participants may be withdrawn from the study if they fail to comply with the study protocol, experience significant adverse events, or withdraw consent. The trial will utilize a **double-blind** methodology to ensure unbiased results, with neither participants nor investigators aware of the treatment allocations. The study aims to provide robust data on the safety and efficacy of PRGF eye drops in managing dry eye disease, potentially offering a new therapeutic option for 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**, which is a structurally diverse substance derived from blood. The eye drops are administered via the **ophthalmic route**. The dosage regimen involves administering 0.4 ml of the eye drops four times daily, with a maximum total dose of 33.6 ml over a treatment period of 12 weeks. Participant compliance with the dosing schedule is monitored throughout the study to ensure adherence to the treatment protocol.
In addition to the experimental treatment, the study includes a comparator treatment using **Artific 3,20 mg/ml colirio en solución**, which is also formulated as **eye drops, solution**. The active substance in this comparator is **hypromellose**, a polymer used in artificial tears and other indifferent preparations. The administration route is ophthalmic, with a dosage of 0.4 ml administered four times daily, matching the experimental treatment's schedule. The maximum total dose for this comparator is also 33.6 ml over a 12-week period.
Another comparator treatment used in the study is **Hidrathea 9 mg/ml colirio en solución**, which is similarly formulated as **eye drops, solution**. The active substance is **sodium chloride**, a chemical commonly used in artificial tears. This treatment is administered via the ophthalmic route, with a dosage of 0.4 ml four times daily. However, the maximum total dose for this comparator is 5.6 ml, with a shorter treatment period of 2 weeks. Compliance with the dosing schedule for both comparator treatments is monitored to ensure accurate assessment of their efficacy and safety in comparison to the experimental treatment.
Efficacy
The efficacy of the investigational product, **Plasma rich in growth factors** (PRGF) eye drops, will be assessed in a randomized, parallel-group, double-blind clinical trial involving patients with dry eye disease. The primary efficacy endpoints include the subjective evolution of patients' symptomatology using the Ocular Surface Disease Index (OSDI) questionnaire and the change in ocular surface staining at 12 weeks, evaluated using the Oxford scale. Secondary efficacy endpoints will be measured at both 2 and 12 weeks and include the subjective evolution of symptomatology using the OSDI questionnaire, changes in global pathology symptoms using the Visual Analog Scale (VAS), changes in best corrected visual acuity (LogMAR VA), changes in tear quantity using Schirmer's test, changes in time to tear film breakage (TBUT), and intraocular pressure (IOP).
The OSDI questionnaire will be utilized to capture patient-reported outcomes regarding symptom severity and impact on daily activities. The Oxford scale will be employed to assess ocular surface staining, providing a standardized method for evaluating corneal and conjunctival damage. Schirmer's test will be conducted to measure tear production, while TBUT will be used to assess tear film stability. Visual acuity will be measured using the LogMAR scale, and IOP will be monitored to ensure ocular safety. These assessments will be conducted at specified timepoints, including baseline, 2 weeks, and 12 weeks, to evaluate the efficacy of PRGF eye drops compared to artificial tear eye drops containing 0.3% hypromellose.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patients aged at least 18 years
- 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.
- OSDI test ≥ 23.
- Patients who have previously signed informed consent.
- Willingness to perform all study visits and procedures.
Exclusion Criteria
- 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.
- 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.
- 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.
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Spain | Not Yet Recruiting | 01 Apr 2025 | 54 |
Sites & Investigators
Research sites
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Artific 3,20 mg/ml colirio en solución | Comparator | COLIRIO EN SOLUCIÓN | OPHTHALMIC USE | 0.4 | 12 | PRD5834546 |
Hidrathea 9 mg/ml colirio en solución | Comparator | COLIRIO EN SOLUCIÓN | OPHTHALMIC USE | 0.4 | 2 | PRD320308 |
Plasma rich in growth factors | Test | EYE DROPS | OPHTHALMIC USE | 0.4 | 12 | PRD11318462 |