NCT01843894

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

A Phase 1/2, First-in-Human, Double-Masked, Placebo-Controlled, Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of RU-101 Ophthalmic Solution in Patients With Severe Dry Eye

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: R-Tech Ueno, Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a Phase 1/2, first-in-human, multicenter, dose escalation, double-masked, placebo controlled study consisting of two stages. In Stage I, 3 cohorts are planned to evaluate escalating doses of RU 101 ophthalmic solution, instilled 6 times daily into each eye for 4 weeks (28 days). Each cohort will comprise 4 patients randomized 3:1 to RU-101 or placebo. A masked safety data review will be performed prior to each dose escalation to determine if any dose limiting toxicities (DLTs) occurred and to define the MTD or highest dose to be used in Stage II. In Stage II, an expanded cohort will receive the dose defined in Stage I (MTD or highest dose if MTD is not reached), instilled 6 times daily into each eye for 12 weeks (84 days). The expanded cohort will comprise approximately 96 patients randomized 1:1 to RU-101 or placebo, provided in a double-masked manner.

Conditions

• Dry Eye

Interventions

Type	Name	Description
BIOLOGICAL	RU-101	Recombinant human serum albumin

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-05-01
• Last updated: 2019-09-11

Locations

1 site across 1 country: United States