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

Primary Purpose

Keratoconjunctivitis Sicca, Dry Eye

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rebamipide 2% ophthalmic suspension
placebo eye drops
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • East Valley Ophthalmology
  • Arizona Center for Clinical Trials, LLC
  • Cornea Consultants of Arizona
  • Macy Eye Center
  • Corneal Consultants of Colorado
  • Specialty Eye Care
  • Cohen Laser and Vision Center
  • Florida Eye Microsurgical Institute, Inc.
  • Med Eye Associates
  • George R. John, MD
  • Central Maine Eye Care
  • Ora, Inc.
  • Ophthalmology Associates
  • Nevada Eye Care Professionals
  • Avista Eye Center
  • New York Ophthalmology, PC
  • Mundorf Eye Center
  • Black Hills Regional Eye Institute
  • The Cataract & Glaucoma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rebamipide 2% ophthalmic suspension

placebo eye drops

Arm Description

Outcomes

Primary Outcome Measures

Central corneal clearing as measured by fluorescein staining

Secondary Outcome Measures

Ocular staining
Dry eye symptoms

Full Information

First Posted
January 25, 2010
Last Updated
January 9, 2012
Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01057147
Brief Title
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Subjects With Dry Eye - Effects on Central Cornea
Official Title
A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects With Keratoconjunctivitis Sicca (Dry Eye)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca, Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rebamipide 2% ophthalmic suspension
Arm Type
Experimental
Arm Title
placebo eye drops
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rebamipide 2% ophthalmic suspension
Intervention Description
Instill one drop in each eye four times daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo eye drops
Intervention Description
Instill one drop in each eye four times daily for 12 weeks.
Primary Outcome Measure Information:
Title
Central corneal clearing as measured by fluorescein staining
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Ocular staining
Time Frame
12 weeks
Title
Dry eye symptoms
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older Diagnosis of dry eye as defined by the protocol Central corneal staining 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryo Kubota, MD, PhD
Organizational Affiliation
Kubota Vision Inc.
Official's Role
Study Director
Facility Information:
Facility Name
East Valley Ophthalmology
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Arizona Center for Clinical Trials, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States
Facility Name
Cornea Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Macy Eye Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Corneal Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Specialty Eye Care
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Cohen Laser and Vision Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Med Eye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
George R. John, MD
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Central Maine Eye Care
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Ophthalmology Associates
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Nevada Eye Care Professionals
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Avista Eye Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89131
Country
United States
Facility Name
New York Ophthalmology, PC
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
The Cataract & Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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