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Hope for rare eye infection: polihexanide shows promise in small study

NCT ID NCT06641882

Disease control Sponsor: SIFI SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks back at medical records of 40 people with acanthamoeba keratitis, a rare but serious eye infection. All patients received 0.8 mg/ml polihexanide eye drops as part of a compassionate use program. Researchers want to see how many patients were cured, defined as having a clear cornea, no significant inflammation, and no need for surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
polihexanide 0.8 mg/ml eye drops
What this could lead to
If successful, this could confirm that polihexanide is an effective treatment for acanthamoeba keratitis, potentially reducing the need for surgery.
What could go wrong
This is a small, retrospective chart review with only 40 patients, not a controlled trial. Results may not apply to all patients, and the definition of cure is limited to short-term outcomes.

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

40 people

The number who actually took part.

Started

Sep 2024

Finished

Sep 2025

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

Subjects included in the study will be patients who have received 0.8 mg/ml polihexanide through the CUP. Clinical sites with at least 3 patients in the CUP will be selected.

Ages

14 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.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>14 years. * Clinical signs and symptoms consistent with AK. * Identification of Acanthamoeba (diagnostic confirmation of AK) by at least one of the allowed techniques as: * Confocal Microscopy * PCR, * Identification by microbiological culture or cytological smear. * Accept to sign the informed consent. Additional inclusion criteria: * Inclusion in the compassionate use program from 1st December 2022 to 31st December 2023 (date of approval by the local Ethics Committee). * Treatment with 0.8 mg/ml polihexanide. * End of treatment with 0.8 mg/ml polihexanide. * Medical chart available at clinical site. Exclusion Criteria: None

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Conditions

The condition(s) this trial relates to.

Acanthamoeba keratitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acanthamoeba keratitis

Contacts and locations

Locations

  • ASST Fatebenefratelli Sacco

    Milan, Milano, 20157, Italy

  • ASST Spedali Civili

    Brescia, Brescia, 25121, Italy

  • AZIENDA ULSS 3 Serenissima-UOC Oculistica

    Venice, Italy, 6777, Italy

  • Azienda Ospedaliera Universitaria Verona

    Verona, Verona, 37126, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Italy, 20132, Italy

  • Policlinico G.Martino

    Messina, Messina, 98124, Italy

  • Policlinico S. Matteo

    Pavia, Pavia, 27100, Italy

  • Policlinico TorVergata

    Rome, Rome, 00133, Italy

  • Policlinico Universitario Campus Biomedico

    Rome, Rome, 00133, Italy

  • SOD Oculistica Azienda Ospedaliero Universitaria Careggi

    Florence, Italy, 50134, Italy

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