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

NCT06463678 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IVIEW-1201-FUN- II
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fungal Keratitis

Outcome Measures

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.

  Day 29 ± 1 day

Secondary Outcomes (2)

• Fungal clearance

  Day 29 ± 1 day

• Best-corrected visual acuity

  Baseline (Day 1) and Day 29 ± 1 day

Study Arms (2)

IVIEW-1201

EXPERIMENTAL

Drug: IVIEW-1201

NATACYN®

ACTIVE COMPARATOR

Drug: NATACYN®

Interventions

IVIEW-1201 DRUG

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

IVIEW-1201

NATACYN® DRUG

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

NATACYN®

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 1.
• 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.

You may not qualify if:

• 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-1201.
• Systemic use of antifungal drugs within 14 days prior to screening.
• 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).
• Participation in other interventional clinical trials within 30 days prior to the trial.
• 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.
• Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.

Sponsors & Collaborators

• IVIEW Therapeutics Inc.: lead

MeSH Terms

Interventions

Natamycin

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Bo Liang, PhD

CONTACT

609 773 8580; bliang@iviewinc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 18, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10