Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis (NCT06463678) | Clinical Trial Compass
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 range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.