Parasitic Ulcer Treatment Trial (PUTT)

At a glance

Phase

Phase 3

Study type

Interventional

Sponsor

Jeremy Keenan, MD, MPH

Enrolment target

232

Started

1 July 2024

Main results due (estimated)

July 2029

Study ends (estimated)

July 2029

Allocation

Randomized

Design

Parallel

Purpose

Treatment

Masking

Quadruple (participant, care provider, investigator, outcomes assessor)

Sites

22 · 2 in India

First posted

19 January 2024

Registry updated

1 October 2026

Can you take part?

• Aged 8 years and over.
• Open to any sex.
• You need the condition being studied. Healthy volunteers are not accepted.

Age groups: child, adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

What this study is about

In the sponsor’s own words, from the registry.

Keywords: corneal ulcer · steroids

What participants receive

• Experimental

  Topical steroids

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

  Drug: Polyhexamethylene biguanide (PHMB) · Drug: Topical corticosteroid

• Placebo comparator

  Topical placebo

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

  Drug: Polyhexamethylene biguanide (PHMB) · Other: Topical placebo

What the study measures

Who is running it

Lead sponsor

Jeremy Keenan, MD, MPH

Sponsor type

Other

Responsible party

Jeremy Keenan, MD, MPH, Professor of Ophthalmology/Director of International Programs at the Proctor Foundation, University of California, San Francisco (sponsor-investigator)

Organisation

University of California, San Francisco

Collaborators

Johns Hopkins University, Oregon Health and Science University, University of Illinois at Chicago, University of Pittsburgh, University of Pennsylvania, Columbia University, University of Iowa, University of Florida, Aravind Eye Care System, Moorfields Eye Hospital NHS Foundation Trust, Federal University of São Paulo, National Eye Institute (NEI), University of Miami, Baylor College of Medicine, University of Colorado, Denver

US FDA-regulated drug

Yes

US FDA-regulated device

No

Sponsor's study ID

23-39559

Other IDs

UG1EY033284

• Jeremy Keenan, MD, MPH

  Principal investigator

  Proctor Foundation, UCSF

• Gerami Seitzman, MD

  Principal investigator

  Proctor Foundation, UCSF

Study sites(22)

References and data sharing

Participant data shared

Yes

What is shared

Study protocol, Sap, Icf

When

After publication of the main results

Access

Request by email addressed to principal investigator.

IPD available on request.