deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03274895

Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis

Randomized, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% PHMB Ophthalmic Solution in Comparison With 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba Keratitis

Sponsor: SIFI SpA

Updated 10 times since 2017 Last updated: Aug 2, 2023 Started: Aug 13, 2017 Primary completion: Jun 30, 2021 Completion: Mar 30, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03274895, this PHASE3 trial focuses on Acanthamoeba Keratitis and remains completed. Sponsored by SIFI SpA, it has been updated 10 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Oct 2017 – ~Sep 2018 · 11 months · monthly snapshotRecruiting~Sep 2018 – ~Sep 2020 · 24 months · monthly snapshotRecruiting~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshotUnknown Status~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Nov 2022 · 22 months · monthly snapshotActive Not Recruiting~Nov 2022 – ~Sep 2023 · 10 months · monthly snapshotUnknown Status~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Sep 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Unknown StatusCompleted

  5. Nov 2022 — Sep 2023 [monthly]

    Unknown Status PHASE3

    Status: Active Not RecruitingUnknown Status

Show 5 earlier versions
  1. Jan 2021 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

  2. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

    Status: Unknown StatusActive Not Recruiting

  3. Sep 2020 — Nov 2020 [monthly]

    Unknown Status PHASE3

    Status: RecruitingUnknown Status

  4. Sep 2018 — Sep 2020 [monthly]

    Recruiting PHASE3

  5. Oct 2017 — Sep 2018 [monthly]

    Recruiting PHASE3

    First recorded

Aug 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • SIFI SpA
Data source: SIFI SpA

For direct contact, visit the study record on ClinicalTrials.gov .