Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis
Condition: Acanthamoeba Keratitis
MeSH terms: Acanthamoeba Keratitis; Keratitis
Intervention: PHMB 0.08%; Propamidine 0.1%; placebo; PHMB 0.02%
Intervention description: 16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution; 16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution; 16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution; 16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
Intervention MeSH terms: Biguanides; Polihexanide; Dibrompropamidine; Propamidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: polihexanide; propamidine; confocal microscopy

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. willing to give informed consent

          2. man or woman of any race and ≥12 years of age

          3. able to understand and willing to comply with study procedures, restrictions and
             requirements

          4. Clinical findings consistent with Acanthamoeba keratitis

          5. Confocal microscopy findings consistent with Acanthamoeba keratitis

          6. The following previous treatments for Acanthamoeba keratitis are eligible:
             antibiotics, antiviral and antifungal drugs, antiinflammatory drugs

          7. Females of childbearing potential will be included if they are either sexually
             inactive or using one highly effective contraceptive

          8. 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

          9. A female of non-childbearing potential must have undergone one sterilization
             procedures at least 6 months prior to the first study drug dose

         10. 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.

         11. If male, they must agree not to donate sperm from the first study drug dose until 90
             days after dosing

        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.