Trials / Not Yet Recruiting
Not Yet RecruitingNCT06463678
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 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
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- IVIEW Therapeutics Inc. · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IVIEW-1201 | 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. |
| DRUG | NATACYN® | 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. |
Timeline
- Start date
- 2026-08-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
- First posted
- 2024-06-18
- Last updated
- 2025-10-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06463678. Inclusion in this directory is not an endorsement.