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Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea

NCT01057147 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2012-01-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.

Conditions

  • Keratoconjunctivitis Sicca
  • Dry Eye

Interventions

DRUG

rebamipide 2% ophthalmic suspension

Instill one drop in each eye four times daily for 12 weeks.

DRUG

placebo eye drops

Instill one drop in each eye four times daily for 12 weeks.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Kubota Vision Inc.

    lead INDUSTRY

Principal Investigators

  • Ryo Kubota, MD, PhD · 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
2010-02-28
Primary Completion
2011-01-31
Completion
2011-02-28

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 NCT01057147 on ClinicalTrials.gov