Not Yet RecruitingPhase 2

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

60 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range15 Years

SexALL

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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 ≥ 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.

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.

What they're measuring

Clinical cure rate

Timeframe: Day 29 ± 1 day

Trial details

NCT IDNCT06463678

SponsorIVIEW Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Bo Liang, PhD

609 773 8580 bliang@iviewinc.com

View on ClinicalTrials.gov More Fungal Keratitis trials