| Eligibility |
Inclusion Criteria:
1. 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.
2. Aged above 15 (inclusive), male or female.
3. Preliminary diagnosis of fungal keratitis based on medical history and clinical
observations: corneal focus score = 1.
4. 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).
5. Not treated with antifungal drugs within 48 hours.
6. Willing to cooperate in the completion of all procedures and visits required for the
trial.
Exclusion Criteria:
1. 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).
2. 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.
3. Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction and patients
with life-threatening or severe unstable underlying diseases.
4. Those with other combined infectious ocular surface diseases.
5. Those with sclera involvement.
6. Those with combined corneal perforation or imminent perforation.
7. 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.
8. Those who would need to wear corneal contact lenses during the trial.
9. Those who add other medications to treat fungal infections during the trial (except
non-facial local treatment).
10. Those who are using other drugs that may interfere with the efficacy or safety
evaluation of IVIEW-1201.
11. Systemic use of antifungal drugs within 14 days prior to screening.
12. 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).
13. Participation in other interventional clinical trials within 30 days prior to the
trial.
14. 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.
15. Other conditions or illnesses judged by the clinical investigator to be unsuitable for
enrollment.
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