Parasitic Ulcer Treatment Trial Pilot

Acanthamoeba Keratitis Clinical Trial

Official title: Parasitic Ulcer Treatment Trial Pilot

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Acanthamoeba keratitis is a rare eye infection that is difficult to treat. The mainstay of therapy is a biguanide agent such as chlorhexidine, though recent studies have found povidone iodine to be effective for killing acanthamoeba organisms in vitro. Thus, we randomize participants to topical chlorhexidine 0.04% monotherapy (i.e., routine care) versus topical chlorhexidine 0.04% plus topical poviodine iodine 2.5%. The primary outcome is clearance of acanthamoeba from the ocular surface at 4 weeks.

The role of topical corticosteroids in acanthamoeba keratitis is controversial. Topical corticosteroids can promote growth of acanthamoeba, but may also reduce inflammation and vision-threatening complications of infection. Here, we randomize participants who have completed a course of anti-amoebic therapy to one of three groups: early prednisolone sodium phosphate 1% (started at 4 weeks), late prednisolone sodium phosphate 1% (started at 6 weeks) or placebo (started at 4 weeks). The primary outcome will be visual acuity at 6 months. ;

Related Conditions & MeSH terms

• Acanthamoeba Keratitis
• Keratitis

• NCT number: NCT03484507
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2018
• Completion date: December 31, 2024