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Parasitic Ulcer Treatment Trial Pilot

NCT03484507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-05-07

No results posted yet for this study

Summary

This is a study of optimal treatments for acanthamoeba keratitis. In the first part of the study, participants will be randomized to chlorhexidine monotherapy or chlorhexidine plus povidone iodine. After four weeks of therapy, participants will be re-randomized to early corticosteroids, later corticosteroids, or placebo.

Conditions

  • Acanthamoeba Keratitis

Interventions

DRUG

Chlorhexidine

1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit

DRUG

Povidone-Iodine

1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit

DRUG

Prednisolone Sodium Phosphate

1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11

DRUG

Hydroxypropyl Methylcellulose

1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11

DRUG

Prednisolone Sodium Phosphate

1 drop 4 times daily for weeks 6-9, then 2 times daily for weeks 10-11

DRUG

Hydroxypropyl Methylcellulose

1 drop 4 times daily for weeks 4-5

Sponsors & Collaborators

Principal Investigators

  • Jeremy D Keenan, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-11-15
Completion
2022-11-15

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03484507 on ClinicalTrials.gov