NCT03484507

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

March 24, 2018

Last Update Submit

April 27, 2026

Conditions

Acanthamoeba Keratitis

Outcome Measures

Primary Outcomes (2)

  • Trial 1: Microbial clearance

    Acanthamoeba culture

    4 weeks

  • Trial 2: Best spectacle corrected visual acuity

    6 months

Secondary Outcomes (4)

  • Trial 1: Best spectacle corrected visual acuity

    4 weeks

  • Trial 1: Time to re-epithelialization

    4 weeks

  • Trial 1: Clinical cure

    4 weeks

  • Trial 2: Time to clinical cure

    6 months

Study Arms (5)

Chlorhexidine monotherapy

ACTIVE COMPARATOR

Topical chlorhexidine 0.04%

Drug: Chlorhexidine

Chlorhexidine plus povidone iodine

EXPERIMENTAL

Topical chlorhexidine 0.04% plus povidone iodine 2.5%

Drug: ChlorhexidineDrug: Povidone-Iodine

Early corticosteroids

EXPERIMENTAL

Topical prednisolone sodium phosophate 1% for weeks 4-11

Drug: Prednisolone Sodium Phosphate

Late corticosteroids

EXPERIMENTAL

Artificial tears for weeks 4-5, then topical prednisolone sodium phosophate 1% for weeks 6-11

Drug: Prednisolone Sodium PhosphateDrug: Hydroxypropyl Methylcellulose

Placebo

PLACEBO COMPARATOR

Artificial tears for weeks 4-11

Drug: Hydroxypropyl Methylcellulose

Interventions

ChlorhexidineDRUG

1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit

Chlorhexidine monotherapyChlorhexidine plus povidone iodine
Povidone-IodineDRUG

1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit

Chlorhexidine plus povidone iodine
Prednisolone Sodium PhosphateDRUG

1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11

Early corticosteroids
Hydroxypropyl MethylcelluloseDRUG

1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11

Placebo

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Smear or culture positive for acanthamoeba
  • Age 13 years or greater

You may not qualify if:

  • 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)
  • Smear or culture positive for acanthamoeba, with 4 weeks of anti-amoebic treatment
  • Age 13 years or greater
  • Willing to participate in study
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aravind Eye Hospital

Coimbatore, Tamil Nadu, India

Location

Aravind Eye Hospital

Madurai, Tamil Nadu, India

Location

Related Publications (1)

  • Rajaraman R, Kassaye I, Sharma SS, Prajna NV, Lalitha P, Panigrahi A, Rammohan R, Aromin KM, Cook C, Porco TC, Lietman TM, Seitzman GD, Keenan JD. Adjunctive povidone-iodine for Acanthamoeba keratitis: a randomized trial. Antimicrob Agents Chemother. 2026 Mar 31:e0151225. doi: 10.1128/aac.01512-25. Online ahead of print.

    PMID: 41914638DERIVED

MeSH Terms

Conditions

Acanthamoeba Keratitis

Interventions

ChlorhexidinePovidone-Iodineprednisolone phosphateHypromellose Derivatives

Condition Hierarchy (Ancestors)

Eye Infections, ParasiticParasitic DiseasesInfectionsAmebiasisProtozoan InfectionsKeratitisCorneal DiseasesEye DiseasesEye Infections

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureCelluloseGlucansBiopolymersPolysaccharidesCarbohydrates

Study Officials

  • Jeremy D Keenan, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2018

First Posted

March 30, 2018

Study Start

January 1, 2018

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)