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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. ;


Study Design


Related Conditions & MeSH terms


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

See also
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Active, not recruiting NCT02506257 - Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects Phase 1
Enrolling by invitation NCT03461978 - Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures N/A
Recruiting NCT02763605 - Retrospective Study of Acanthamoebic Keratitis During the Past 10 Years N/A
Recruiting NCT05110001 - Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction Phase 3
Completed NCT03274895 - Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis Phase 3
Not yet recruiting NCT06213649 - Parasitic Ulcer Treatment Trial Phase 3