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

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ClinicalTrials.gov Identifier: NCT03274895
Recruitment Status : Unknown
Verified October 2020 by SIFI SpA.
Recruitment status was:  Active, not recruiting
First Posted : September 7, 2017
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
SIFI SpA

Study Description
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Brief Summary:

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

A total of 130 subjects will be assigned to one of the following 2 treatment groups:

Group 1: 0.08% PHMB + placebo Group 2: 0.02% PHMB + 0.1% propamidine combination therapy


Condition or disease Intervention/treatment Phase
Acanthamoeba Keratitis Drug: PHMB 0.08% Drug: Propamidine 0.1% Drug: placebo Drug: PHMB 0.02% Phase 3

Detailed Description:

This is a randomized, assessor-masked, active-controlled, multiple center, parallel-group Phase 3 study to evaluate the efficacy, safety and tolerability of 0.08% PHMB ophthalmic solution compared to the conventional 0.02% PHMB + 0.1% propamidine combination therapy in male and female subjects affected by Acanthamoeba keratitis.

The study is designed as a superiority study with the possibility to test for non-inferiority if the superiority hypothesis is not met, according to the requirements of the guidance from the European Agency for the Evaluation of Medicinal Products (EMA) (CPMP/EWP/482/99).The study consists of an eligibility screening visit, a treatment period including short ambulant visits, and follow-up visits. A total of approximately 130 subjects affected by Acanthamoeba keratitis will be assigned to one of the following 2 treatment groups in a ratio of 1:1.

Group 1: 0.08% PHMB + placebo Group 2: 0.02% PHMB + 0.1% propamidine combination therapy

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% PHMB Ophthalmic Solution in Comparison With 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba Keratitis
Actual Study Start Date : August 13, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PHMB 0.08% plus placebo
16 drops each in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution
 Drug: PHMB 0.08%
16 drops in a day for 5 days,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
Other Name: Polyhexamethylene Biguanide 0.08%

Drug: placebo
16 drops in a day for 5 days,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
Other Name: Brolene vehicle
Active Comparator: PPHMB 0.02% plus propamidine 0.1%
16 drops each in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution
 Drug: Propamidine 0.1%
16 drops in a day for 5 days,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
Other Name: Brolene eye drops

Drug: PHMB 0.02%
16 drops in a day for 5 days,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
Other Name: Polyhexamethylene Biguanide 0.02%


Outcome Measures
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Primary Outcome Measures :
  1. Clinical resolution rate [ Time Frame: 12 months ]
    Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274895


Locations
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Italy
San Raffaele Hospital
Milano, Italy
SS Giovanni E Paolo Hospital
Venice, Italy
Poland
University Clinical Center Medical University of Silesia
Katowice, Poland
United Kingdom
Moorfields Hospital
London, United Kingdom
Manchester Royal Eye Hospital
Manchester, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Sponsors and Collaborators
SIFI SpA
Investigators
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Principal Investigator: John Dart, MD Moorfield's Hospital London
More Information
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Responsible Party: SIFI SpA
ClinicalTrials.gov Identifier: NCT03274895    
Other Study ID Numbers: 043SI
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acanthamoeba Keratitis
Keratitis
Corneal Diseases
Eye Diseases
Eye Infections, Parasitic
Parasitic Diseases
Infections
Amebiasis
Protozoan Infections
Eye Infections
Biguanides
 Polihexanide
Dibrompropamidine
Propamidine
Hypoglycemic Agents
Physiological Effects of Drugs
Disinfectants
Anti-Infective Agents
Anti-Infective Agents, Local
Antiprotozoal Agents
Antiparasitic Agents