Fungal KeratitisPhase 2NCT06463678
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
A Phase 2 study testing IVIEW-1201 and NATACYN® in people with Fungal Keratitis, run by IVIEW Therapeutics Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Fungal Keratitis
- What is being tested?
- IVIEW-1201 and NATACYN®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2027to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Being tested
- IVIEW-1201, NATACYN®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIEW-1201Drug
Also called Treatment Arm
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.
NATACYN®Drug
Also called Active Comparator Arm
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.
| Study group | Role | What they receive |
|---|---|---|
| IVIEW-1201 | Experimental | Not described Receives: Drug: IVIEW-1201 |
| NATACYN® | Active comparator | Not described Receives: Drug: NATACYN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 29 ± 1 day
Secondary outcomes (2)
Fungal clearance
Positive if fungal hyphae are visible on smear microscopy or confocal microscopy at baseline and negative if no fungal hyphae are visible on smear microscopy or confocal microscopy at the last visit.
Measured: Day 29 ± 1 day
Best-corrected visual acuity
The best-corrected visual acuity and its distribution ratio with 0.3, 0.6 and 1.0 LogMAR as cut-offs of test eyes in the test and control groups at baseline and at the last visit. A stratified analysis is carried out to calculate the change in best-corrected visual acuity.
Measured: Baseline (Day 1) and Day 29 ± 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Dec 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVIEW Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463678
- Sponsor's protocol ID
- IVIEW-1201-FUN- II
- Status last verified
- Nov 2026
- First submitted
- 11 Jun 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06463678
- Acronym / sponsor ID
- IVIEW-1201-FUN- II
- Conditions
- Fungal Keratitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IVIEW Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVIEW-1201 | Experimental | Drug: IVIEW-1201 |
| NATACYN® | Active comparator | Drug: NATACYN® |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIEW-1201Also: Treatment ArmShake 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. | Drug | IVIEW-1201 |
| NATACYN®Also: Active Comparator ArmShake 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. | Drug | NATACYN® |
Primary outcome
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.
2 secondary outcomes
Fungal clearance
Time frame: Day 29 ± 1 day
Best-corrected visual acuity
Time frame: Baseline (Day 1) and Day 29 ± 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IVIEW-1201 and NATACYN® in people with Fungal Keratitis, run by IVIEW Therapeutics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Liang, PhD (609 773 8580, bliang@iviewinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: Day 29 ± 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.