drugset / Trial / NCT05816070

Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis

NCT05816070 ↗

Phase 2 Completed 129 enrolled IVIEW Therapeutics Inc.
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

EvaluationDrugModalityDoseRoute
Comparator Ofloxacin Small molecule — Other
Subject Povidone-Iodine Other / unclassified 1 % Other