Acanthamoeba keratitis MedDRA version: 20.0 Level: PT Classification code 10069408 Term: Acanthamoeba keratitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Polyhexamethylene biguanide hydrochloride 0.08%
Product Code: PHMB 0.08%
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: POLIHEXANIDE
CAS Number: 32289-58-0
Current Sponsor
Sponsors
SIFI SpA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be able and willing to give informed consent. 2. Subject must be a man or woman of any race and =12 years of age, inclusive. Subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject with documented history and/or clinical signs of concomitant presence of an ocular infection caused by viruses (herpes simplex virus [HSV]) or fungi. 2. Subject treated with drugs having effects on Acanthamoeba cysts prior to study entry, including biguanides (PHMB, chlorhexidine) and diamidines (propamidine, hexamidine). 3. Subjects requiring systemic immunosuppression for Acanthamoeba associated scleritis. 4. Subjects requiring urgent surgical intervention for advanced Acanthamoeba keratitis in either eye (e.g., for advanced corneal thinning/melting etc.). 5. Subject with known or suspected allergy to biguanides, diamidines or intolerance to any other ingredient of the investigational treatments. 6. Subject affected by immunodeficiency diseases or taking systemic immunosuppressive therapy. 7. Subject with a major systemic disease or other illness that would, in the opinion of the investigator, compromise subject’s safety or interfere with the collection or interpretation of study results. 8. If female, pregnancy, planned pregnancy, or breast-feeding. 9. Subject is participating in another interventional clinical study with an experimental or unapproved/unlicensed therapy or has participated in another interventional clinical study within 4 weeks prior to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: A further aim of this study is to obtain additional safety information on 0.08% PHMB ophthalmic solution.;Main Objective: The primary objective of the study is to compare the Clinical Resolution Rate (CRR) at 12 months (CRR_12 ) of 0.08% PHMB + placebo with that of 0.02% PHMB + 0.1% propamidine combination therapy, estimating the difference in CRR_12 together with the surrounding degree of uncertainty, and to test for therapeutic superiority or non-inferiority of 0.08% PHMB monotherapy. ;Primary end point(s): Clinical Response Rate;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy parameters are: • BCVA • Corneal scarring as identified by slit lamp examination • Ulceration severity as identified by slit lamp examination using a 2 grade scoring procedure • Anterior chamber inflammation as identified by ophthalmoscopy using a 3 grade scoring procedure • EQ-5D questionnaire • VFQ25 questionnaire Secondary safety parameters are: • Adverse events • Clinical laboratory tests • Intraocular pressure (IOP) • Opthalmoscopy • Worsening of the corneal epithelial defect and definable inflammatory signs (development of ring abscess and hypopyon) despite >30 days of treatment with the study drug) • Rate of subjects with a relapse • Rate of subjects requiring surgery, including amniotic membrane transplants, superficial keratectomy, application of cyanoacrylate glue, therapeutic penetrating, lamellar keratoplasty, cataract surgery, evisceration, or enucleation • Rate of subjects requiring non-study therapies, e.g., topical steroids and NSAIDs • Rate of subject discontinuation from study: to permit alteration of anti-amoebic therapy or for other unrelated specified reasons. • Incidence of secondary complications, such as significant corneal neovascularization, corneal scarring, corneal perforation, scleritis, secondary glaucoma, cataract, retinopathy.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy, Poland, United Kingdom
Contacts
Public ContactJolanda Overweel
PSR Orphan Experts
Outcome results
None listed