Status:
COMPLETED
Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis
Lead Sponsor:
SIFI SpA
Conditions:
Acanthamoeba Keratitis
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief 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...
Detailed Description
This was a randomized, assessor-masked, active-controlled, multiple center, parallel-group phase 3 study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) ophthalmic solut...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- 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.
Key Trial Info
Start Date :
August 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03274895
Start Date
August 13 2017
End Date
March 30 2022
Last Update
August 22 2023
Active Locations (6)
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1
San Raffaele Hospital
Milan, Italy
2
San Giovanni and Paolo Hospital
Venice, Italy
3
University Clinical Center Medical University of Silesia
Katowice, Poland
4
Moorfields Hospital
London, United Kingdom