Parasitic Ulcer Treatment Trial Pilot

Acanthamoeba Keratitis Clinical Trial

Official title:

Parasitic Ulcer Treatment Trial Pilot

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03484507
• Other study ID #: UCSF-IRB-17-23895
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acanthamoeba Keratitis
• Keratitis

Intervention

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
• 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
• Prednisolone Sodium Phosphate
1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11
• Hydroxypropyl Methylcellulose
1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11
• Prednisolone Sodium Phosphate
1 drop 4 times daily for weeks 6-9, then 2 times daily for weeks 10-11
• Hydroxypropyl Methylcellulose
1 drop 4 times daily for weeks 4-5

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Coimbatore	Tamil Nadu
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Research to Prevent Blindness

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trial 1: Microbial clearance	Acanthamoeba culture	4 weeks
Primary	Trial 2: Best spectacle corrected visual acuity		6 months
Secondary	Trial 1: Best spectacle corrected visual acuity		4 weeks
Secondary	Trial 1: Time to re-epithelialization		4 weeks
Secondary	Trial 1: Clinical cure		4 weeks
Secondary	Trial 2: Time to clinical cure		6 months