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Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

NCT01632137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2014-05-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

Rebamipide 2% ophthalmic suspension

Instill one drop into each eye 4 times a day for 4 weeks.

DRUG

Placebo (vehicle)

Instill one drop into each eye 4 times a day for 4 weeks.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Kubota Vision Inc.

    lead INDUSTRY

Principal Investigators

  • Acucela Medical Monitor · Kubota Vision Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30

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 NCT01632137 on ClinicalTrials.gov