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| Name | Class |
|---|---|
| Research to Prevent Blindness | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine monotherapy | Active Comparator | Topical chlorhexidine 0.04% |
|
| Chlorhexidine plus povidone iodine | Experimental | Topical chlorhexidine 0.04% plus povidone iodine 2.5% |
|
| Early corticosteroids | Experimental | Topical prednisolone sodium phosophate 1% for weeks 4-11 |
|
| Late corticosteroids | Experimental | Artificial tears for weeks 4-5, then topical prednisolone sodium phosophate 1% for weeks 6-11 |
|
| Placebo | Placebo Comparator | Artificial tears for weeks 4-11 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | 1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trial 1: Microbial clearance | Acanthamoeba culture | 4 weeks |
| Trial 2: Best spectacle corrected visual acuity | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Trial 1: Best spectacle corrected visual acuity | 4 weeks | |
| Trial 1: Time to re-epithelialization | 4 weeks | |
| Trial 1: Clinical cure |
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Trial 1 Inclusion Criteria:
Trial 1 Exclusion Criteria:
Trial 2 Inclusion Criteria
Trial 2 Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy D Keenan, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aravind Eye Hospital | Coimbatore | Tamil Nadu | India | |||
| Aravind Eye Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41914638 | Derived | 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 May 6;70(5):e0151225. doi: 10.1128/aac.01512-25. Epub 2026 Mar 31. |
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| ID | Term |
|---|---|
| D015823 | Acanthamoeba Keratitis |
| ID | Term |
|---|---|
| D015822 | Eye Infections, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000562 | Amebiasis |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D011206 | Povidone-Iodine |
| C009022 | prednisolone phosphate |
| D065347 | Hypromellose Derivatives |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007466 |
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| Povidone-Iodine | Drug | 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 | Drug | 1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11 |
|
| Hydroxypropyl Methylcellulose | Drug | 1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11 |
|
| Prednisolone Sodium Phosphate | Drug | 1 drop 4 times daily for weeks 6-9, then 2 times daily for weeks 10-11 |
|
| Hydroxypropyl Methylcellulose | Drug | 1 drop 4 times daily for weeks 4-5 |
|
| 4 weeks |
| Trial 2: Time to clinical cure | 6 months |
| Madurai |
| Tamil Nadu |
| India |
| D011528 |
| Protozoan Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015817 | Eye Infections |
| Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002482 | Cellulose |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |