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CompletedNCT01632137Updated May 7, 2014

Efficacy and Safety of Rebamipide in Subjects With Dry Eye Syndrome

A Phase 3 interventional study of Rebamipide 2% ophthalmic suspension and Placebo (vehicle) in Dry Eye Syndrome, sponsored by Kubota Vision Inc.. Completed at 34 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-07.

Sponsored by Kubota Vision Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
564
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Dry Eye Syndrome
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 192 are open to participants now.

This study's enrollment of 564 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

  • History of dry eye-related ocular symptoms for at least 20 months.
  • Meet protocol-defined criteria for corneal and conjunctival staining.
  • Meet protocol-defined criteria for ocular discomfort.

Exclusion criteria

Exclusion Criteria:

  • Active anterior segment ocular disease other than dry eye syndrome.
  • Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
  • Inability to suspend the use of contact lenses for the duration of the study.
  • Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
  • Received any other investigational product within 4 months before the screening visit.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
564 participants (actual)

Study arms

  • Placebo comparator
    Placebo (vehicle)

    Drug: Placebo (vehicle)

  • Experimental
    Rebamipide 2% ophthalmic suspension

    Drug: Rebamipide 2% ophthalmic suspension

Interventions

  • DrugRebamipide 2% ophthalmic suspension

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

  • DrugPlacebo (vehicle)

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

06

What researchers measure

Primary outcomes

  1. Primary ocular sign: Fluorescein corneal staining total score

    Time frame: 4 weeks

  2. Primary ocular symptom: Worst ocular symptom severity score

    Time frame: 4 weeks

Secondary outcomes

  1. Fluorescein corneal staining total score

    Time frame: 2 weeks

  2. Worst ocular symptom severity score

    Time frame: 2 weeks

07

Study locations

34 sites
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Artesia, California, United States
  • Glendale, California, United States
  • Inglewood, California, United States
  • San Diego, California, United States
  • Wheat Ridge, Colorado, United States
  • Fort Myers, Florida, United States
  • Miami, Florida, United States
  • Plantation, Florida, United States
  • Stuart, Florida, United States
  • Tampa, Florida, United States
  • Morrow, Georgia, United States
  • Baton Rouge, Louisiana, United States
  • Lutherville, Maryland, United States
  • Kansas City, Missouri, United States
  • Saint Louis, Missouri, United States
  • Washington, Missouri, United States
  • Las Vegas, Nevada, United States
  • Princeton, New Jersey, United States
  • Rochester, New York, United States
  • Rockville Centre, New York, United States
  • Valley Stream, New York, United States
  • Wantagh, New York, United States
  • Ashville, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Mason, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Chattanooga, Tennessee, United States
  • Memphis, Tennessee, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Norfolk, Virginia, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01632137
Lead sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 2, 2012
Start date
Jun 2012
Primary completion
Jun 2013
Last update
May 7, 2014

Study contacts

Acucela Medical Monitor
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 Apr 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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