Parasitic Ulcer Treatment Trial
Recruiting
Phase 3
Interventional Study
Acanthamoeba Keratitis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 8 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 232 (estimated)
- Sponsor
- Jeremy Keenan, MD, MPH · Other
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About This Trial
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 ocul…
Trial Locations
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Eligibility Criteria
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:
* Ev…
Contacts