Parasitic Ulcer Treatment Trial

Acanthamoeba Keratitis Clinical Trial

— PUTT  

Official title:

Parasitic Ulcer Treatment Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06213649
• Other study ID #: 23-39559
• Secondary ID: UG1EY033284
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: April 2028

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: Jeremy Keenan, MD, MPH
• Phone: 415-476-6323
• Email: jeremy.keenan[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 232
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acanthamoeba Keratitis
• Keratitis

Intervention

Drug:
• Polyhexamethylene biguanide (PHMB)
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 corticosteroid
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.

Other:
• Topical placebo
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.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo
India	Aravind Eye Hospitals	Madurai	Tamil Nadu
United Kingdom	Moorfields Eye Hospital	London
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Illinois, Chicago	Chicago	Illinois
United States	University of Florida	Gainesville	Florida
United States	University of Iowa	Iowa City	Iowa
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of California, San Francisco	San Francisco	California

Sponsors (15)

Lead Sponsor

Collaborator

Jeremy Keenan, MD, MPH

Aravind Eye Care System, Columbia University, Federal University of São Paulo, Johns Hopkins University, Moorfields Eye Hospital NHS Foundation Trust, National Eye Institute (NEI), Oregon Health and Science University, University of California, Los Angeles, University of Florida, University of Illinois at Chicago, University of Iowa, University of Miami, University of Michigan, University of Pennsylvania

Countries where clinical trial is conducted

United States,  Brazil,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision	Best corrected visual acuity	6 Months
Secondary	Self-reported eye pain	Pain visual analog scale (Likert scale from 0 to 10; 0=no pain, 10=worst pain)	2 months
Secondary	Clinical Resolution	Time until clinical resolution (i.e., healed ocular surface and absence of inflammation)	12 months
Secondary	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	6 Months