CompletedPhase 2

Parasitic Ulcer Treatment Trial Pilot

India49 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Trial 1: Microbial clearance

Timeframe: 4 weeks

Trial 2: Best spectacle corrected visual acuity

Timeframe: 6 months

Trial details

NCT IDNCT03484507

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-15

View on ClinicalTrials.gov More Acanthamoeba Keratitis trials