drugset / Trial / NCT01843894

A Phase 1/2, RU-101 Ophthalmic Solution in Patients With Severe Dry Eye

NCT01843894 ↗

Phase 1/2 Completed 104 enrolled R-Tech Ueno, Ltd.
RandomizedSingle-groupDouble-blindTreatment

Summary

Objectives: Primary * To determine the safety and tolerability of escalating doses of RU-101 for 4 weeks in patients with severe dry eye Secondary * To explore the efficacy of RU-101 * To explore optimal endpoints for future studies

Timeline

Start
2013-04
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject RU-101 Protein / enzyme biologic 5 % Topical
Subject RU-101 Protein / enzyme biologic 10 % Topical
Subject RU-101 Protein / enzyme biologic 15 % Topical

Indications