Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Subjects Affected by Acanthamoeba Keratitis

 Acanthamoeba Keratitis / Posted 3 years ago

Phase 3 study to evaluate the efficacy, safety and tolerability of 0.08% PHMB ophthalmic solution in subjects affected by Acanthamoeba keratitis.

  • Inclusion Criteria :
    • willing to give informed consent
    • man or woman of any race and over 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
    • A female of non-childbearing potential must have undergone one sterilization procedures at least 6 months prior to the first study drug dose
    • A non-vasectomized male subject agrees 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 the female partner agrees to comply with inclusion 7 or 8. For a vasectomized male who has had his vasectomy 6 months or more prior to study start, it is required that they use a condom during sexual intercourse. A male who has been vasectomized less than 6 months prior to study start must follow the same restrictions as a non-vasectomized male.
    • If male, they must agree not to donate sperm from the first study drug dose until 90 days after dosing
  • 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 subjects safety or interfere with the collection or interpretation of study results.
    • If female, pregnancy, planned pregnancy, or breast-feeding
    • 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.
  • Study start date : 13/08/2017
  • Study end date : 30/06/2020
  • Wales-Based Study Contact : please speak to your clinician
  • Principal Investigator : John Dart, MD
Contact details

Moorfields Hospital Recruiting London, United Kingdom Contact: John Dart, MD; Manchester Royal Eye Hospital Recruiting Manchester, United Kingdom Contact: Fiona Carley, MD; University Hospital Southampton Recruiting Southampton, United Kingdom Contact: Parwez Hossain, MD England vincenzo.papa@sifigroup.com www.clinicaltrials.gov

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