Parasitic Ulcer Treatment Trial Pilot

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Francis I. Proctor Foundation; University of California, San Francisco
• Collaborator: Research to Prevent Blindness
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Iodine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Povidone; Povidone-Iodine; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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)