drugset / Trial / NCT06213649
Parasitic Ulcer Treatment Trial
Phase 3
Recruiting
232 enrolled
Jeremy Keenan, MD, MPH
Aravind Eye Care System · collabBaylor College of Medicine · collabColumbia University · collabFederal University of São Paulo · collabJohns Hopkins University · collabMoorfields Eye Hospital NHS Foundation Trust · collabNational Eye Institute (NEI) · collabOregon Health and Science University · collabUniversity of Colorado Denver - Anschutz Medical Campus (UCD-AMC) · collabUniversity of Florida · collabUniversity of Illinois at Chicago · collabUniversity of Iowa · collabUniversity of Miami · collabUniversity of Pennsylvania · collabUniversity of Pittsburgh · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2024-07-01
- Primary completion
- 2029-07
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 0.1 % | Topical |
| Background | Polihexanide | Other / unclassified | — | Topical |