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

NCT01843894 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-09-11

No results posted yet for this study

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

Conditions

  • Dry Eye

Interventions

BIOLOGICAL

RU-101

Recombinant human serum albumin

Sponsors & Collaborators

  • R-Tech Ueno, Ltd.

    lead INDUSTRY

Principal Investigators

  • John Sheppard, MD · Virginia Ehe Consultants

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01843894 on ClinicalTrials.gov