Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
ConditionFungal Keratitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorIVIEW Therapeutics Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
IVIEW-1201
DrugShake 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®
DrugShake 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: IVIEW-1201Experimental treatment 1 intervention
Group B: NATACYN®Active comparator 1 intervention
Trial outcomes
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.
Time frame
Day 29 ± 1 daySecondary outcomes
1
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.
Time frame
Day 29 ± 1 day2
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.
Time frame
Baseline (Day 1) and Day 29 ± 1 dayLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: