BridgeMD
New treatment option for Acanthamoeba Keratitis
Official title Parasitic Ulcer Treatment Trial
ClinicalTrials.gov ID: NCT06213649
What this study is testing
What is Polyhexamethylene biguanide (PHMB)?
Polyhexamethylene biguanide (PHMB) is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for acanthamoeba keratitis.
Also referred to as Polyhexanide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy
- Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation
You likely can't join if
- Evidence or history of interstitial keratitis
- Known herpetic keratitis, as determined from history, exam, or microbiological testing
- Known fungal keratitis, as demonstrated from corneal scrapings
- Corneal perforation or impending corneal perforation
- Prior therapeutic keratoplasty for acanthamoeba keratitis
- Unwillingness or inability to follow-up
See the full eligibility criteria
- AK on at least one of the following: culture, smear, PCR, shotgun sequencing, biopsy, or confocal microscopy
- Ocular inflammation after 1 month of anti-amoebic treatment, defined as conjunctival, corneal, episcleral, or anterior chamber inflammation
- Evidence or history of interstitial keratitis
- Known herpetic keratitis, as determined from history, exam, or microbiological testing
- Known fungal keratitis, as demonstrated from corneal scrapings
- Corneal perforation or impending corneal perforation
- Prior therapeutic keratoplasty for acanthamoeba keratitis
- Unwillingness or inability to follow-up
- No light perception in the affected eye
- Known hypertensive response to steroids
- Corticosteroid allergy
- Concurrent treatment with systemic corticosteroids
- Concurrent granulomatous amoebic encephalitis
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Aurora, Colorado, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- São Paulo, Brazil
- Coimbatore, Tamil Nadu, India
- Madurai, Tamil Nadu, India
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Aurora, Colorado, United States; Gainesville, Florida, United States; Miami, Florida, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.