NCT03484507

Parasitic Ulcer Treatment Trial Pilot

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acanthamoeba Keratitis

Interventions

Type	Name	Description
DRUG	Chlorhexidine	1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit
DRUG	Povidone-Iodine	1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit
DRUG	Prednisolone Sodium Phosphate	1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11
DRUG	Hydroxypropyl Methylcellulose	1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11
DRUG	Prednisolone Sodium Phosphate	1 drop 4 times daily for weeks 6-9, then 2 times daily for weeks 10-11
DRUG	Hydroxypropyl Methylcellulose	1 drop 4 times daily for weeks 4-5

Timeline

• Start date: 2018-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-03-30
• Last updated: 2024-02-06

Locations

2 sites across 1 country: India