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CompletedNCT01027013Updated Jan 11, 2012

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

A Phase 2 interventional study of rebamipide 2% ophthalmic suspension and placebo eye drops in Dry Eye Syndromes and Keratoconjunctivitis Sicca, sponsored by Kubota Vision Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-11.

Sponsored by Kubota Vision Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.

02

Conditions studied

  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 220 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Kubota Vision Inc. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 years and older
  • Diagnosis of dry eye as defined by the protocol

Exclusion criteria

Exclusion Criteria:

  • Ongoing ocular disease that may interfere with study parameters.
  • Inability to stop using topical ophthalmic medications throughout the duration of the study
  • Inability to stop the use of contact lenses for the duration of the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    rebamipide 2% ophthalmic suspension

    Drug: rebamipide 2% ophthalmic suspension

  • Placebo comparator
    Placebo eye drops

    Drug: placebo eye drops

Interventions

  • Drugrebamipide 2% ophthalmic suspension

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

  • Drugplacebo eye drops

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

06

What researchers measure

Primary outcomes

  1. Total fluorescein corneal staining score

    Time frame: 4 weeks

  2. Primary ocular discomfort

    Time frame: 4 weeks

Secondary outcomes

  1. Dry eye symptoms

    Time frame: 12 weeks

  2. Ocular staining

    Time frame: 12 weeks

07

Study locations

5 sites
  • The Eye Care Group, P.C.
    Waterbury, Connecticut 06708, United States
  • Richard Eiferman, MD
    Louisville, Kentucky 40205, United States
  • Central Maine Eye Care
    Lewiston, Maine 04240, United States
  • Ora, Inc
    Andover, Massachusetts 01810, United States
  • Total Eye Care, P.A.
    Memphis, Tennessee 38119, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01027013
Lead sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 7, 2009
Start date
Dec 2009
Primary completion
Oct 2010
Completion
Nov 2010
Last update
Jan 11, 2012

Study contacts

Nancy Boman, MD, PhD
study director · Kubota Vision Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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