Acanthamoeba KeratitisNCT07195864
Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/mL Polihexanide as Part of the "Medicines in Special Situations" (Medicamentos en Situaciones Especiales) Program in Spain.
An observational study of Acanthamoeba Keratitis, run by SIFI SpA at 5 sites in Spain.
Trial summary
The study will be a multicentric, retrospective, non-interventional medical chart review of patients with AK who initiated a treatment with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program, whether they fully completed the treatment or not. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acanthamoeba Keratitis
- What is being tested?
- PHMB 0.08%
- How many people
- 23 participants
- Where
- 5 sitesSpain
- Study dates
- 30 Oct 2025to 11 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- No participation in another trial contemporary at this one
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
HU La Paz
Madrid, Madrid
IO Fernandez Vega
Madrid, Madrid
HU Ramon y Cajal
Madrid, Principality of Asturias
CHUO Ourense
Ourense, Ourense
Hospital la Fé
Valencia, Valencia, 46026
About this study
The study will be a multicentric, retrospective, non-interventional medical chart review of patients with AK who initiated a treatment with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program, whether they fully completed the treatment or not.
Baseline date is defined as the date of 0.8 mg/ml polihexanide initiation. The Study Period for each patient will be considered the period from the baseline to the conclusion of the treatment.
Read the detailed description
Primary objective:
- To describe the efficacy of 0.8 mg/ml polihexanide in the clinical resolution of AK in all patients that satisfy the inclusion criteria of the study, as measured by the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available).
Secondary objectives:
- To describe the efficacy of 0.8 mg/ml polihexanide in the clinical resolution of AK in full compliant patients.
- To describe the efficacy of 0.8 mg/ml polihexanide in the improvement of visual acuity (VA).
- To describe the efficacy of 0.8 mg/ml polihexanide in the improvement of ocular clinical findings.
- To describe de efficacy of 0.8 mg/ml polihexanide in the reduction of pain.
- To determine the rate of patients requiring ocular surgery.
- To determine the rate of patients using topical ophthalmologic steroids or other relevant medications.
- To determine the time from start of treatment until clinical resolution.
- To determine the proportion of patients with concomitant fungal or bacterial corneal infections.
- To describe the efficacy of 0.8 mg/ml polihexanide in preventing disease relapse.
- Conditions
- Acanthamoeba Keratitis
- Being tested
- PHMB 0.08%
- Keywords
- Acanthamoeba Keratitis PHMB
- Medical subject headings
- Acanthamoeba Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHMB 0.08%Drug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available)
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available). The primary analysis will be performed on all patients that satisfy the inclusion criteria of the study
Measured: The end of the study period, confirmed at the 30-day follow-up (when available).
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available).
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available). The primary analysis will be performed on all patients that satisfy the inclusion criteria of the study.
Measured: he end of the study period, confirmed at the 30-day follow-up (when available).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Oct 2025
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acanthamoeba KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195864
- Sponsor's protocol ID
- 059/SI
- Status last verified
- Jun 2026
- First submitted
- 2 Sep 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review of Patients With Acanthamoeba Keratitis Who Have Received 0.8 mg/mL Polihexanide as Part of the "Medicines in Special Situations" (Medicamentos en Situaciones Especiales) Program in Spain.
- ClinicalTrials.gov ID
- NCT07195864
- Acronym / sponsor ID
- 059/SI
- Conditions
- Acanthamoeba Keratitis
- Keywords
- Acanthamoeba Keratitis PHMB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be a multicentric, retrospective, non-interventional medical chart review of patients with AK who initiated a treatment with 0.8 mg/ml polihexanide as part of the Spanish Medicines in Special Situations program, whether they fully completed the treatment or not.
Baseline date is defined as the date of 0.8 mg/ml polihexanide initiation. The Study Period for each patient will be considered the period from the baseline to the conclusion of the treatment.
Detailed description
Primary objective:
- To describe the efficacy of 0.8 mg/ml polihexanide in the clinical resolution of AK in all patients that satisfy the inclusion criteria of the study, as measured by the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available).
Secondary objectives:
- To describe the efficacy of 0.8 mg/ml polihexanide in the clinical resolution of AK in full compliant patients.
- To describe the efficacy of 0.8 mg/ml polihexanide in the improvement of visual acuity (VA).
- To describe the efficacy of 0.8 mg/ml polihexanide in the improvement of ocular clinical findings.
- To describe de efficacy of 0.8 mg/ml polihexanide in the reduction of pain.
- To determine the rate of patients requiring ocular surgery.
- To determine the rate of patients using topical ophthalmologic steroids or other relevant medications.
- To determine the time from start of treatment until clinical resolution.
- To determine the proportion of patients with concomitant fungal or bacterial corneal infections.
- To describe the efficacy of 0.8 mg/ml polihexanide in preventing disease relapse.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- No participation in another trial contemporary at this one
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHMB 0.08%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. | Drug | – |
Primary outcome
the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available)
Time frame: The end of the study period, confirmed at the 30-day follow-up (when available).
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available). The primary analysis will be performed on all patients that satisfy the inclusion criteria of the study
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available).
Time frame: he end of the study period, confirmed at the 30-day follow-up (when available).
The primary endpoint will be the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available). The primary analysis will be performed on all patients that satisfy the inclusion criteria of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acanthamoeba Keratitis, run by SIFI SpA at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients cured at the end of the study period, confirmed at the 30-day follow-up (when available) (time frame: The end of the study period, confirmed at the 30-day follow-up (when available).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.