Acanthamoeba keratitis Eye Diseases Acanthamoeba keratitis
Conditions
Interventions
Participants will be recruited from participating hospitals, and their subsequent study visits will take place in the same hospitals. Routine baseline investigations for Acanthamoeba keratitis are car
Sponsors
SIFI Medtech (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be able and willing to give informed consent 2. Aged =12 years, subjects <18 years will only be enrolled in selected study sites 3. Able to understand and willing to comply with study procedures, restrictions, and requirements as judged by the investigator 4. Clinical findings consistent with Acanthamoeba keratitis 5. Confocal microscopy findings consistent with Acanthamoeba keratitis (performed within 7 days prior to study entry or as part of screening procedures) 6. Previously used antibiotics, antiviral and antifungal drugs, or anti-inflammatory drugs treatment for Acanthamoeba keratitis 7. Women of childbearing potential who agree to remain either sexually inactive (sexually abstinent for 14 days prior to the first study drug dose continuing through 28 days after the last study drug dose) or using the same highly effective contraceptive method (results in <1% failure rate when used consistently and correctly) for at least 28 days following the last study drug dose 8. Women of non-childbearing potential who have undergone sterilization procedures and have had these procedures =6 months prior to the first study drug dose 9. Non-vasectomized men with a partner of childbearing potential who agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug and a partner who agrees to comply with points 7 and 8 10. Vasectomized men who have had their vasectomy =6 months prior to study start who agree use a condom during sexual intercourse, or men who have had a vasectomy <6 months prior to study start who agree to follow the same restrictions as described in point 9 11. Men who agree not to donate sperm from the first study drug dose until 90 days the last dose of the study drug
Exclusion criteria
Exclusion criteria: 1. Documented history and/or clinical signs of concomitant presence of an ocular infection caused by viruses (such as herpes simplex virus) or fungi 2. Treated with drugs having effects on Acanthamoeba cysts prior to study entry, including biguanides (PHMB, chlorhexidine) and diamidines (propamidine, hexamidine) 3. Require systemic immunosuppression for Acanthamoeba associated scleritis 4. Require urgent surgical intervention for advanced Acanthamoeba keratitis in either eye (such as for advanced corneal thinning/melting) 5. Known or suspected allergy to biguanides, diamidines, or intolerance to any other ingredient of the investigational treatments 6. Immunodeficiency disease or taking systemic immunosuppressive therapy 7. Major systemic disease or other illness that would, in the opinion of the investigator, compromise the subject’s safety or interfere with the collection or interpretation of study results 8. Pregnancy, planned pregnancy, or breast-feeding 9. Participating in another interventional clinical study with an experimental or unapproved/unlicensed therapy or has participated in another interventional clinical study within the 4 weeks prior to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical resolution rate at 12 months from randomization (CRR_12) measured using slit-lamp examination at baseline, weekly between weeks 1 and 4 until symptoms resolve, monthly between 1 and 11 months until symptoms resolve, and 1 and 3 months post-discontinuation of treatment. CRR_12 is defined as the percentage of subjects with an absence of signs of clinical inflammation (conjunctival redness, corneal inflammation (seen as a cellular infiltrate +/- oedema) on slit-lamp examination maintained for 1 month after discontinuing all study therapies, and confirmed by a repeat examination 3 months after discontinuing all study therapies. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Best-corrected visual acuity (BCVA) measured using spectacles with a pinhole (at the final visit there will be full refraction with spectacles and, for participants with central scarring, vision will be tested with a rigid contact lens) at baseline and on discontinuation of treatment 2. Acanthamoeba keratitis signs measured using slit-lamp examination to detect the following at baseline, weekly between weeks 1 and 4 until symptoms resolve, monthly between 1 and 11 months until symptoms resolve, and 1 and 3 months post-discontinuation of treatment: 2.1. Presence or absence of corneal scarring 2.2. Ulceration severity, ulceration location (epithelial or stromal), and presence or absence of ulceration 2.3. Anterior chamber inflammation grade (0–4) 3. Overall health and eyesight measured using the Euroqol 5 dimension (EQ-5D) quality of life questionnaire and the Visual Function Questionnaire 25 (VFQ25) at baseline, weekly between weeks 1 and 4 until symptoms resolve, monthly between 1 and 11 months until symptoms resolve, and 1 and 3 months post-discontinuation of treatment 4. Safety measured using the following at baseline, weekly between weeks 1 and 4 until symptoms resolve, monthly between 1 and 11 months until symptoms resolve, and 1 and 3 months post-discontinuation of treatment (unless otherwise stated): 4.1. Adverse events tabulated together with the detailed outcomes of the discontinued subjects by 3 months post-discontinuation of treatment 4.2. Clinical laboratory tests of routine blood tests (U&E, LFT’s, and haematology parameters) at baseline and termination 4.3. Intraocular pressure (IOP) determined by tonometry 4.4. Rate of pupil, cataract, vitreous, optic disc, and retinal abnormalities determined by slit lamp examination and ophthalmoscopy 4.5. Worsening of the corneal epithelial | — |
Countries
England, Italy, Poland, United Kingdom
Contacts
Public ContactSebastiano Giuffrida
Outcome results
None listed