NCT01057147

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 25, 2010

Last Update Submit

January 9, 2012

Conditions

Keratoconjunctivitis SiccaDry Eye

Outcome Measures

Primary Outcomes (1)

  • Central corneal clearing as measured by fluorescein staining

    12 weeks

Secondary Outcomes (2)

  • Ocular staining

    12 weeks

  • Dry eye symptoms

    12 weeks

Study Arms (2)

rebamipide 2% ophthalmic suspension

EXPERIMENTAL
Drug: rebamipide 2% ophthalmic suspension

placebo eye drops

PLACEBO COMPARATOR
Drug: placebo eye drops

Interventions

rebamipide 2% ophthalmic suspensionDRUG

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

rebamipide 2% ophthalmic suspension
placebo eye dropsDRUG

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

placebo eye drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

East Valley Ophthalmology

Mesa, Arizona, 85206, United States

Location

Arizona Center for Clinical Trials, LLC

Phoenix, Arizona, 85003, United States

Location

Cornea Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Macy Eye Center

Los Angeles, California, 90048, United States

Location

Corneal Consultants of Colorado

Littleton, Colorado, 80120, United States

Location

Specialty Eye Care

Parker, Colorado, 80134, United States

Location

Cohen Laser and Vision Center

Boca Raton, Florida, 33431, United States

Location

Florida Eye Microsurgical Institute, Inc.

Boynton Beach, Florida, 33426, United States

Location

Med Eye Associates

Miami, Florida, 33143, United States

Location

George R. John, MD

Louisville, Kentucky, 40205, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Nevada Eye Care Professionals

Las Vegas, Nevada, 89119, United States

Location

Avista Eye Center

Las Vegas, Nevada, 89131, United States

Location

New York Ophthalmology, PC

Manhasset, New York, 11030, United States

Location

Mundorf Eye Center

Charlotte, North Carolina, 28204, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

The Cataract & Glaucoma Center

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis SiccaDry Eye Syndromes

Interventions

rebamipide

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesLacrimal Apparatus Diseases

Study Officials

  • Ryo Kubota, MD, PhD

    Kubota Vision Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 27, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

US(19)