23 patients treated: new hope for rare eye infection?
NCT ID NCT07195864
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked back at medical records of 23 people in Spain who had a rare eye infection called acanthamoeba keratitis. All patients were treated with polihexanide eye drops as part of a special access program. The main goal was to see how many were cured after treatment, with a follow-up 30 days later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- polihexanide (PHMB) 0.08% eye drops
- What this could lead to
- If results are positive, this could support the use of polihexanide as a standard treatment for acanthamoeba keratitis, a rare but serious eye infection.
- What could go wrong
- This is a small, retrospective review of only 23 patients, not a controlled trial. Results may not apply to all patients, and the study cannot prove cause and effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
23 people
The number who actually took part.
- Started
-
Oct 2025
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population for this study is patients diagnosed with AK treated with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program.
- Ages
-
12 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participation in the Spanish Medicines in Special Situations (Gestión de Medicamentos en Situaciones Especiales) program from August 2022 to 31 October 2024, because they presented clinical signs and symptoms consistent with AK and the identification of Acanthamoeba was confirmed by at least one of the following techniques: o Confocal Microscopy o PCR o Identification by microbiological culture or cytological smear. • Diagnosis of AK at least 2 months before inclusion in the study • Age ≥12 years at the time of diagnosis. • To have started and completed the treatment with 0.8 mg/ml polihexanide at the moment of the inclusion. Exclusion Criteria: * No participation in another trial contemporary at this one
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHUO Ourense
Ourense, Ourense, Spain
-
HU La Paz
Madrid, Madrid, Spain
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HU Ramon y Cajal
Madrid, Principality of Asturias, Spain
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Hospital la Fé
Valencia, Valencia, 46026, Spain
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IO Fernandez Vega
Madrid, Madrid, Spain
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