Parasitic Ulcer Treatment Trial Pilot

UCSF-IRB-17-23895

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.

2018-01-01

2024-12-31

2024-12-31

Active (not recruiting)

Early phase I

49

Trial 1 Inclusion Criteria: * Smear or culture positive for acanthamoeba * Age 13 years or greater Trial 1 Exclusion Criteria: * Interstitial or viral keratitis on history or examination * Corneal perforation * Therapeutic keratoplasty for acanthamoeba keratitis * Unwillingness or inability to follow-up (e.g., living too far from hospital) Trial 2 Inclusion Criteria * Smear or culture positive for acanthamoeba, with 4 weeks of anti-amoebic treatment * Age 13 years or greater * Willing to participate in study Trial 2 Exclusion Criteria * Interstitial or viral keratitis on history or examination * Fungus identified on culture and smear after 2 weeks of anti-amoebic treatment * Corneal perforation * Therapeutic keratoplasty for acanthamoeba keratitis * Unwillingness or inability to follow-up (e.g., living too far from hospital)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

2024-02-06