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