NCT06213649

Brief Summary

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:

  • Group 1: Topical corticosteroid
  • Group 2: Topical placebo

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P25-P50 for phase_3

Timeline
38mo left

Started Jul 2024

Longer than P75 for phase_3

Geographic Reach
4 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Jul 2024Jul 2029

First Submitted

Initial submission to the registry

January 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

January 9, 2024

Last Update Submit

April 27, 2026

Conditions

Acanthamoeba Keratitis

Keywords

corneal ulcersteroids

Outcome Measures

Primary Outcomes (1)

  • Vision

    Best corrected visual acuity

    6 Months

Secondary Outcomes (3)

  • Self-reported eye pain

    2 months

  • Clinical Resolution

    12 months

  • Multivariate Analysis

    6 Months

Study Arms (2)

Topical steroids

EXPERIMENTAL

Participants in this arm will receive anti-amoebic therapy plus topical steroids.

Drug: Polyhexamethylene biguanide (PHMB)Drug: Topical corticosteroid

Topical placebo

PLACEBO COMPARATOR

Participants in this arm will receive anti-amoebic therapy plus topical placebo.

Drug: Polyhexamethylene biguanide (PHMB)Other: Topical placebo

Interventions

Polyhexamethylene biguanide (PHMB)DRUG

PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug.

Also known as: Polyhexanide
Topical placeboTopical steroids
Topical corticosteroidDRUG

Dexamethasone sodium phosphate, 0.1% ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.

Topical steroids
Topical placeboOTHER

An artificial tear ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks.

Topical placebo

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy
  • Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation

You may not qualify if:

  • Evidence or history of interstitial keratitis
  • Known herpetic keratitis, as determined from history, exam, or microbiological testing
  • Known fungal keratitis, as demonstrated from corneal scrapings
  • Corneal perforation or impending corneal perforation
  • Prior therapeutic keratoplasty for acanthamoeba keratitis
  • Unwillingness or inability to follow-up
  • No light perception in the affected eye
  • Known hypertensive response to steroids
  • Corticosteroid allergy
  • Concurrent treatment with systemic corticosteroids
  • Concurrent granulomatous amoebic encephalitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

University of Florida

Gainesville, Florida, 32605, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

Federal University of São Paulo

São Paulo, Brazil

RECRUITING

Aravind Eye Hospital

Coimbatore, Tamil Nadu, India

RECRUITING

Aravind Eye Hospital

Madurai, Tamil Nadu, India

RECRUITING

Moorfields Eye Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acanthamoeba KeratitisCorneal Ulcer

Interventions

polihexanideAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Eye Infections, ParasiticParasitic DiseasesInfectionsAmebiasisProtozoan InfectionsKeratitisCorneal DiseasesEye DiseasesEye Infections

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Jeremy Keenan, MD, MPH

    Proctor Foundation, UCSF

    PRINCIPAL INVESTIGATOR

  • Gerami Seitzman, MD

    Proctor Foundation, UCSF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Keenan, MD, MPH

CONTACT

415-476-6323jeremy.keenan@ucsf.edu

Krisi Aromin

CONTACT

krisianne.aromin@ucsf.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Ophthalmology/Director of International Programs at the Proctor Foundation

Study Record Dates

First Submitted

January 9, 2024

First Posted

January 19, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

IPD available on request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication of the main results
Access Criteria
Request by email addressed to principal investigator.

Locations

IN(2)BR(1)GB(1)US(13)