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| ID | Type | Description | Link |
|---|---|---|---|
| UG1EY033284 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Oregon Health and Science University | OTHER |
| University of Illinois at Chicago | OTHER |
| University of Pittsburgh |
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The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical steroids | Experimental | Participants in this arm will receive anti-amoebic therapy plus topical steroids. |
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| Topical placebo | Placebo Comparator | Participants in this arm will receive anti-amoebic therapy plus topical placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyhexamethylene biguanide (PHMB) | Drug | PHMB is a cationic antiseptic agent used for topical treatment of acanthamoeba keratitis (AK). Both treatment groups will take PHMB at least 4 times daily while on the allocated study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Vision | Best corrected visual acuity | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported eye pain | Pain scale (Likert 11-point ordinal scale from 0 to 10; 0=no pain, 10=worst pain) | 2 months |
| Clinical Resolution | Time until clinical resolution (i.e., healed ocular surface and absence of inflammation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Keenan, MD, MPH | Contact | 415-476-6323 | jeremy.keenan@ucsf.edu | |
| Krisi Aromin | Contact | krisianne.aromin@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeremy Keenan, MD, MPH | Proctor Foundation, UCSF | Principal Investigator |
| Gerami Seitzman, MD | Proctor Foundation, UCSF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94158 | United States |
IPD available on request.
After publication of the main results
Request by email addressed to principal investigator.
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| OTHER |
| University of Pennsylvania | OTHER |
| Columbia University | OTHER |
| University of Iowa | OTHER |
| University of Florida | OTHER |
| Aravind Eye Care System | OTHER |
| Moorfields Eye Hospital NHS Foundation Trust | OTHER |
| Federal University of São Paulo | OTHER |
| National Eye Institute (NEI) | NIH |
| University of Miami | OTHER |
| Baylor College of Medicine | OTHER |
| University of Colorado Denver - Anschutz Medical Campus (UCD-AMC) | UNKNOWN |
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|
| Topical corticosteroid | Drug | Dexamethasone sodium phosphate, 0.1% ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks. |
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| Topical placebo | Other | An artificial tear ophthalmic solution will be administered 4 times daily for 4 weeks, then 2 times daily for 2 weeks, then 1 time daily for 2 weeks. |
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| 12 months |
| Multivariate Analysis | The multivariate analysis will include the following outcomes measured at 6 months: best corrected visual acuity, corneal thinning on optical coherence tomography (OCT), scar density on Scheimpflug imaging, irregular astigmatism, glare, microbial clearance on confocal microscopy, pain score, time until clinical resolution | 6 Months |
| University of Colorado Anschutz | Recruiting | Aurora | Colorado | 80045 | United States |
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| University of Florida | Recruiting | Gainesville | Florida | 32605 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| University of Illinois, Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Columbia University | Recruiting | New York | New York | 10032 | United States |
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| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15219 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
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| Federal University of São Paulo | Recruiting | São Paulo | Brazil |
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| Aravind Eye Hospital | Recruiting | Coimbatore | Tamil Nadu | India |
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| Aravind Eye Hospital | Recruiting | Madurai | Tamil Nadu | India |
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| Moorfields Eye Hospital | Recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D015823 | Acanthamoeba Keratitis |
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015822 | Eye Infections, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000562 | Amebiasis |
| D011528 | Protozoan Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015817 | Eye Infections |
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| ID | Term |
|---|---|
| C031233 | polihexanide |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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