Parasitic Ulcer Treatment Trial Pilot

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT03484507

Collaborator

Research to Prevent Blindness (Other)

150

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acanthamoeba Keratitis	Drug: Chlorhexidine Drug: Povidone-Iodine Drug: Prednisolone Sodium Phosphate Drug: Hydroxypropyl Methylcellulose Drug: Prednisolone Sodium Phosphate Drug: Hydroxypropyl Methylcellulose	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Parasitic Ulcer Treatment Trial Pilot

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chlorhexidine monotherapy Topical chlorhexidine 0.04%	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
Experimental: Chlorhexidine plus povidone iodine Topical chlorhexidine 0.04% plus povidone iodine 2.5%	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
Experimental: Early corticosteroids Topical prednisolone sodium phosophate 1% for weeks 4-11	Drug: Prednisolone Sodium Phosphate 1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11
Experimental: Late corticosteroids Artificial tears for weeks 4-5, then topical prednisolone sodium phosophate 1% for weeks 6-11	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
Placebo Comparator: Placebo Artificial tears for weeks 4-11	Drug: Hydroxypropyl Methylcellulose 1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11