Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02506257 - Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects Phase 1
Not yet recruiting NCT06332703 - Acanthamoeba and Artificial Intelligence
Enrolling by invitation NCT03461978 - Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures N/A
Recruiting NCT02763605 - Retrospective Study of Acanthamoebic Keratitis During the Past 10 Years N/A
Active, not recruiting NCT03484507 - Parasitic Ulcer Treatment Trial Pilot Phase 2
Active, not recruiting NCT05110001 - Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction Phase 3
Completed NCT03274895 - Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis Phase 3