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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03484507
Other study ID # UCSF-IRB-17-23895
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02506257 - Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects Phase 1
Not yet recruiting NCT06332703 - Acanthamoeba and Artificial Intelligence
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
Active, not 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