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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274895
Recruitment Status : Active, not recruiting
First Posted : September 7, 2017
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
SIFI SpA

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 7, 2017
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE August 13, 2017
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
Clinical resolution rate [ Time Frame: 12 months ]
Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Subjects Affected by Acanthamoeba Keratitis
Official Title  ICMJE 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
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

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acanthamoeba Keratitis
Intervention  ICMJE
  • 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: 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: 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
  • 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%
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: PHMB 0.08%
    • Drug: placebo
  • 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
    Interventions:
    • Drug: Propamidine 0.1%
    • Drug: PHMB 0.02%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03274895
Other Study ID Numbers  ICMJE 043SI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party SIFI SpA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE SIFI SpA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Dart, MD Moorfield's Hospital London
PRS Account SIFI SpA
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP