Clinical study to assess the eficaccy and safety of PRGF-Endoret eye drops in patients with neurotrophic keratitis, syages 2 and 3.
- Conditions
- eurotrophic Keratitis (NK)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-003326-13-ES
- Lead Sponsor
- BTI Biotechnology Institute I mas D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Patients aged 18 or over.
2. Patients with neurotrophic keratitis at stages 2 (persistent epithelial defect, PED) or 3 (corneal ulcer) affecting only one eye. Patients with the contralateral eye affected with NK at stage 1 could be included.
3. Persistent epithelial defect or corneal ulcer of at least 2 weeks duration resistant to one or more traditional non-surgical treatments for neurotrophic keratitis (as artificial tears, gels or ointments without preservatives; eye drops discontinuation and medicines for topical use with preservatives which may reduce corneal sensibility; therapeutic contact lenses).
4. Corneal sensitivity reduction test (using ?4 Cochet-Bonnet esthesiometer) in the area of the persistent epithelial defect or corneal ulcer and out of the defect area in at least one corneal quadrant.
5. No objective clinical evidence of improvement in the persistent epithelial defect or corneal ulcer in the two weeks prior to enrollment in the study.
6. Patients who have previously read and signed the informed consent.
7. Patients able and willing to comply with the study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patients with neurotrophic keratitis stages 2 or 3 that affects both eyes.
2. With active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to the neurotrophic keratitis in the affected eye.
3. Any other eye disease that requires of topical ocular treatment in the affected eye during the course of the treatment period of the study.
4. Patients with severe vision loss in the affected eye with no chance of visual improvement (> 50% Wecker scale), in the investigator's opinion, as a result of study treatment.
5. Patients with severe blepharitis and/or severe Meibomian glands disease in the affected eye.
6. History of eye surgery (including surgical or refractive laser procedures) in the affected eye in the three months prior to enter the study (except when it is considered that the eye surgery is the cause of the neurotrophic keratitis stage 2 or 3), or patients who plan to undergo surgery.
7. Having received previously surgical procedures for the treatment of neurotrophic keratitis in the affected eye (eg complete tarsorrhaphy, conjunctival flap, etc.) with the exception of a transplant of the amniotic membrane (includable only two weeks after the disappearance of the membrane in the area of persistent epithelial defect or corneal ulcer, or at least six weeks after the date of the amniotic membrane transplant procedure). Patients previously treated with Botox injections (botulinum toxin) only if the last injection was administered at least 90 days prior to enrollment in the study.
8. Use of therapeutic contact lenses or for refractive correction during the periods of the study treatment in the affected eye.
9. Patients with punctual occlusion or insertion of punctual plugs previous to the study or with an anticipated need for punctual occlusion during the study time.
10. Evidence of corneal ulcer affecting the corneal stroma posterior third, fusion or cornea perforation in the affected eye.
11. Presence or history of any disorder or ocular or systemic disease that could limit the treatment effectiveness or its evaluation, which could interfere with the interpretation of the results or that the investigator could determine incompatible with the schedule of the study visits or with its realization (eg, corneal disorders or progressive or degenerative retinal, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases).
12. Any need of change (at that time or planned) in the dose of systemic drugs known to disrupt the functioning of the trigeminal nerve (eg, neuroleptics, antipsychotics, and antihistamines). These treatments will be allowed during the study if they were started before the 30 days prior to enrollment in the study, provided that they remain stable during the course of the study treatment periods.
13. Known hypersensitivity to any of the procedural compounds (eg. fluoresceine).
14. Presence of blood disorders related to platelet or clotting disorders, or who for whatever reason are receiving anticoagulants or antiplatelet agents.
15. Patients with a positive result in serological tests for syphilis, Hepatitis B, Hepatitis C or HIV I / II.
16. Patient in current treatment for their pathology already well managed.
17. Use of any investigational drug within 4 weeks prior to the screening visit.
18. Pregnant women or intended to be pregnant.
19. Participating in another clinical study while in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of this study is to demonstrate the superiority of the PRGF-Endoret eye drops (Plasma Rich in Growth Factors) administered four times a day, and for 1 month of treatment, in patients with stages 2 and 3 of neurotrophic keratitis, compared to treatment with moustirizing artificial tear drops.;Secondary Objective: The secondary objective of the study is to determine the tolerance and safety of PRGF-Endoret topical eye drops in patients with stages 2 and 3 neurotrophic keratitis.;Primary end point(s): Reduction at 4 weeks of 50% or more of the area of corneal ulcer/keratitis respect to its initial area determined by corneal staining with fluoresceine.;Timepoint(s) of evaluation of this end point: basal, 2 and 4 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Reduction at 2 weeks, of the 50% or more of the area of corneal ulcer/keratitis<br>-Complete healing of the cornea after 4 weeks (100% reduction of corneal ulcer/keratitis).<br>-Partial response (reduction of 75% or more of the area of corneal/keratitis ulcer) at 4 weeks.<br>-Complete corneal healing at two weeks.<br>-Partial response (reduction of 75% or more of the surface of the corneal ulcer/keratitis) at 2 weeks.<br>-Evaluation of the depth of the corneal/keratitis ulcer at 2 and 4 weeks.<br>-Better visual acuity corrected in four weeks (VA LogMAR). The best corrected VA will be measured with the best correction of the patient and will be recorded in LogMAR.<br>-Evaluation of the overall symptoms of the disease (including eye pain) using the VAS score at 2 and 4 weeks..<br>-Osmolarity at 2 and 4 weeks.;Timepoint(s) of evaluation of this end point: Basal, 2 and 4 weeks