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Not yet recruitingNCT06463678Updated Oct 15, 2025

Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis

A Phase 2 interventional study of IVIEW-1201 and NATACYN® in Fungal Keratitis, sponsored by IVIEW Therapeutics Inc.. Not yet recruiting. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-10-15.

Sponsored by IVIEW Therapeutics Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study summary

A Phase II, Multi-center, Randomized, Masked, Parallel-Control Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% PVP-Iodine) Gel Forming Ophthalmic Solution in the Treatment of Fungal Keratitis.

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Conditions studied

  • Fungal Keratitis
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In context

Lead sponsor

IVIEW Therapeutics Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Volunteered to participate in the study and signed the Informed Consent Form after receiving a verbal and written explanation of this clinical trial. In cases where the subject is unable to sign the Informed Consent Form, his/her guardian may sign in accordance with relevant regulations.
  2. Aged above 15 (inclusive), male or female.
  3. Preliminary diagnosis of fungal keratitis based on medical history and clinical observations: corneal focus score ≥ 1.
  4. Fungal infection confirmed by laboratory tests (positive for any of the three: fungal hyphae on scraping examination, fungal hyphae on confocal microscopy, positive fungal culture).
  5. Not treated with antifungal drugs within 48 hours.
  6. Willing to cooperate in the completion of all procedures and visits required for the trial.

Exclusion criteria

Exclusion Criteria:

  1. Patients with systemic or ocular diseases, or functional disorders with comorbidities, or structural abnormalities that, in the judgment of the investigator, could adversely affect the course or results of the trial (e.g., hyperthyroidism, hepatitis, acute and chronic renal insufficiency).
  2. Those who have a history of allergy or serious adverse reactions to any component of IVIEW-1201 and NATACYN®; a history of allergy or serious adverse reactions to polyene macrolides and other antifungal drugs; or have a cumulative total of three or more allergies to other drugs, food and environment; or have a predisposition to allergic symptoms such as rash or urticaria.
  3. Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction and patients with life-threatening or severe unstable underlying diseases.
  4. Those with other combined infectious ocular surface diseases.
  5. Those with sclera involvement.
  6. Those with combined corneal perforation or imminent perforation.
  7. Patients with glaucoma and corneal limbal stem cell abnormalities that cannot be cured at the same time, severe chemical burns of cornea and conjunctiva, corneal foreign bodies and other diseases not suitable for this trial.
  8. Those who would need to wear corneal contact lenses during the trial.
  9. Those who add other medications to treat fungal infections during the trial (except non-facial local treatment).
  10. Those who are using other drugs that may interfere with the efficacy or safety evaluation of IVIEW-1201.
  11. Systemic use of antifungal drugs within 14 days prior to screening.
  12. Systemic use of steroidal drugs within 14 days prior to screening. Local use of eye steroidal drugs or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days before enrollment (nasally or bronchially inhaled steroidal drugs are not allowed at any time during the trial).
  13. Participation in other interventional clinical trials within 30 days prior to the trial.
  14. Pregnant or lactating women, women with positive blood or urine pregnancy tests and those planning to become pregnant (including male subjects); subjects who did not take effective contraceptive measures within 1 month before enrollment, or subjects (including male subjects) who are unwilling to take effective contraceptive measures within the next 6 months.
  15. Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    IVIEW-1201

    Drug: IVIEW-1201

  • Active comparator
    NATACYN®

    Drug: NATACYN®

Interventions

  • DrugIVIEW-1201

    Shake well before use and administer 1 drop into the conjunctival sac every 1 hour on Day 1, 2 and 3 when awake; every 2 hours on Day 4-14 when awake; 6 times a day on Day 15-21 with a dosing interval of at least 2.5 hours; 4 times a day on Day 22-28 with a dosing interval of at least 3 hours. The time course of administration is 28 days. After 14 days of dosing, if a patient reaches the primary and secondary endpoints, the investigational drug can be discontinued at the discretion of the investigator.

    Also known as: Treatment Arm

  • DrugNATACYN®

    Shake well before use and administer 1 drop into the conjunctival sac every 1 hour on Day 1, 2 and 3 when awake; every 2 hours on Day 4-14 when awake; 6 times a day on Day 15-21 with a dosing interval of at least 2.5 hours; 4 times a day on Day 22-28 with a dosing interval of at least 3 hours. The time course of administration is 28 days. After 14 days of dosing, if a patient reaches the primary and secondary endpoints, the investigational drug can be discontinued at the discretion of the investigator.

    Also known as: Active Comparator Arm

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What researchers measure

Primary outcomes

  1. Clinical cure rate

    Proportion of subjects with a score of 0/12. This is manifested by the resolution of clinical symptoms, healing of corneal ulcers, negative fluorescein staining, corneal recovery to translucency or transparency, and resolution of hypopyon.

    Time frame: Day 29 ± 1 day

Secondary outcomes

  1. Fungal clearance

    Positive if fungal hyphae are visible on smear microscopy or confocal microscopy at baseline and negative if no fungal hyphae are visible on smear microscopy or confocal microscopy at the last visit.

    Time frame: Day 29 ± 1 day

  2. Best-corrected visual acuity

    The best-corrected visual acuity and its distribution ratio with 0.3, 0.6 and 1.0 LogMAR as cut-offs of test eyes in the test and control groups at baseline and at the last visit. A stratified analysis is carried out to calculate the change in best-corrected visual acuity.

    Time frame: Baseline (Day 1) and Day 29 ± 1 day

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06463678
Lead sponsor
IVIEW Therapeutics Inc.
Responsible party
Sponsor
First posted
Jun 18, 2024
Start date
Aug 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 15, 2025

Study contacts

Bo Liang, PhD
Contact
bliang@iviewinc.com
609 773 8580

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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