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
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.
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.
Exclusion Criteria:
Drug: IVIEW-1201
Drug: NATACYN®
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
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
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
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
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
No study locations are listed for this record.
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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IVIEW Therapeutics Inc.