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.0 sites60 target enrollmentAugust 1, 2026

ConditionsFungal Keratitis

InterventionsIVIEW-1201 NATACYN®

DrugsIVIEW-1201 NATACYN®

Overview

Phase: Phase 2
Intervention: IVIEW-1201
Conditions: Fungal Keratitis
Sponsor: IVIEW Therapeutics Inc.
Enrollment: 60
Primary Endpoint: Clinical cure rate
Status: Not yet recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 1, 2026

End Date

December 31, 2027

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IVIEW Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Aged above 15 (inclusive), male or female.
•Preliminary diagnosis of fungal keratitis based on medical history and clinical observations: corneal focus score ≥
•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).
•Not treated with antifungal drugs within 48 hours.
•Willing to cooperate in the completion of all procedures and visits required for the trial.

Exclusion Criteria

•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).
•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.
•Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction and patients with life-threatening or severe unstable underlying diseases.
•Those with other combined infectious ocular surface diseases.
•Those with sclera involvement.
•Those with combined corneal perforation or imminent perforation.
•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.
•Those who would need to wear corneal contact lenses during the trial.
•Those who add other medications to treat fungal infections during the trial (except non-facial local treatment).
•Those who are using other drugs that may interfere with the efficacy or safety evaluation of IVIEW-

Arms & Interventions

IVIEW-1201

Intervention: IVIEW-1201

NATACYN®

Intervention: NATACYN®

Outcomes

Primary Outcomes

Clinical cure rate

Time Frame: Day 29 ± 1 day

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.