Parasitic Ulcer Treatment Trial

Phase 3RecruitingNCT06213649

Jeremy Keenan, MD, MPH232 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

232

Conditions

Acanthamoeba Keratitis

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.

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 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.

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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

Locations (16)

University of California, San Francisco

San Francisco, California, United States

RECRUITING

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Vision

Best corrected visual acuity

Time frame: 6 Months

Secondary Outcomes

Self-reported eye pain

Pain scale (Likert 11-point ordinal scale from 0 to 10; 0=no pain, 10=worst pain)

Time frame: 2 months

Clinical Resolution

Time until clinical resolution (i.e., healed ocular surface and absence of inflammation)

Time frame: 12 months

Multivariate Analysis

The multivariate analysis will include the following outcomes measured at 6 months: best corrected visual acuity, corneal thinning on optical coherence tomography (OCT), scar density on Scheimpflug imaging, irregular astigmatism, glare, microbial clearance on confocal microscopy, pain score, time until clinical resolution

Time frame: 6 Months

Central Contacts

Jeremy Keenan, MD, MPH

CONTACT

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

Krisi Aromin

CONTACT

krisianne.aromin@ucsf.edu

Data from ClinicalTrials.gov

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