drugset / Trial / NCT05816070
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis
RandomizedParallel-groupSingle-blindTreatment
Summary
A Phase 2, Multi-center, Randomized, Parallel Controlled Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis
Timeline
- Start
- 2023-01-05
- Primary completion
- 2023-11-13
- Completion
- 2024-10-12
Outcome
Met primary endpoint
registry analysis (non-inferiority test); IVIEW-1201 vs Ofloxacin Eye Drops; p = 0.0137; Chi-squared NCT05816070 ↗
release “positive topline result in the Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis” iviewtherapeutics.com ↗
release “The prespecified primary endpoint (clinical cure rate at Day 8) of non-inferiority to Ofloxacin achieved.” iviewtherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ofloxacin | Small molecule | — | Other |
| Subject | Povidone-Iodine | Other / unclassified | 1 % | Other |