Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis (NCT03274895) | Clinical Trial Compass
CompletedPhase 3
Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis
Italy, Poland, United Kingdom135 participantsStarted 2017-08-13
Plain-language summary
Prospective randomized study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) eye drops in patients affected by acanthamoeba keratitis.
130 subjects were assigned to one of the following 2 treatment groups: Group 1: 0.08% polihexanide (PHMB) + placebo Group 2: 0.02% polihexanide (PHMB) + 0.1% propamidine
Who can participate
Age range13 Years
SexALL
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Inclusion criteria
✓. willing to give informed consent
✓. man or woman of any race and ≥12 years of age
✓. able to understand and willing to comply with study procedures, restrictions and requirements
✓. Clinical findings consistent with Acanthamoeba keratitis
✓. Confocal microscopy findings consistent with Acanthamoeba keratitis
✓. The following previous treatments for Acanthamoeba keratitis are eligible: antibiotics, antiviral and antifungal drugs, antiinflammatory drugs
✓. Females of childbearing potential will be included if they are either sexually inactive or using one highly effective contraceptive
✓. Females of childbearing potential agree to remain sexually inactive or to keep the same birth control method for at least 28 days following the last study drug dose
Exclusion criteria
✕. Subject with documented history and/or clinical signs of concomitant presence of an ocular infection caused by viruses (herpes simplex virus \[HSV\]) or fungi.
✕. Subject treated with drugs having effects on Acanthamoeba cysts prior to study entry, including biguanides (PHMB, chlorhexidine) and diamidines (propamidine, hexamidine).
✕. Subjects requiring systemic immunosuppression for Acanthamoeba associated scleritis.
. Subjects requiring urgent surgical intervention for advanced Acanthamoeba keratitis in either eye (e.g., for advanced corneal thinning/melting etc.).
✕. Subject with known or suspected allergy to biguanides, diamidines or intolerance to any other ingredient of the investigational treatments.
✕. Subject affected by immunodeficiency diseases or taking systemic immunosuppressive therapy.
✕. 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.
✕. If female, pregnancy, planned pregnancy, or breast-feeding