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Study of Rebamipide Eye Drops to Treat Dry Eye

Primary Purpose

Keratoconjunctivitis Sicca

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rebamipide
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring dry eye, keratoconjunctivitis sicca

Eligibility Criteria

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

Inclusion Criteria: must have symptoms of dry eye for a minimum of 6 months must be able to sign and date an informed consent Exclusion Criteria: presence of anterior segment disease glaucoma or ocular hypertension using Restasis use of topically instilled ocular medications during study use of contact lenses history of ocular surgery within 12 months females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception presence of Stevens-Johnson syndrome any anticipated change in medication through-out study concurrent involvement in another study or previous receipt of this drug cannot be safely be weaned off of ocular medications

Sites / Locations

  • Alabama Research Center, LLC
  • Sun Valley Arthritis Center, Ltd.
  • Pivotel Research Center
  • Hope research Institute
  • Buena Vista Eye Care Center
  • Radiant Research
  • Sall Eye Research Center
  • Radiant Research - Irvine
  • Scripps Clinic Medical Group, Inc.
  • American Eye Institute
  • Eye Clinic of San Diego
  • Healthcare Partners Medical Group
  • Centennial Eye Associates
  • Corneal Consultants of Colorado
  • Western States Clinical Research, Inc.
  • Peter C. Donshik, MDPC
  • Opticare Eye Health Center
  • The Eye Associates
  • Hernando Eye Institute
  • Radiant Research, Inc. - Lake Worth
  • Suncoast Clinical Research, Inc.
  • Eye Associates International
  • Pinellas Eye Center
  • Ft. Lauderdale Eye Institute
  • Marvin E. Greenberg, MD PA 7
  • Clinical Research of West Florida, Inc.
  • International Eye Center
  • Omni Eye Services
  • University of Kentucky, Department of Ophthamology
  • Kentucky Lions Eye Center
  • Gulf Coast Research Associates, Inc.
  • Danial Long, MD
  • Lakeview Optical
  • Eye Center Northeast
  • Krieger Eye Institute
  • The Wilmer Eye Institute
  • New England Eye Center
  • The Eye Institute - Lahey Clinic North
  • Mississippi Eye Associates
  • Montana Medical Research, LLC
  • Clinical Research Center of Nevada
  • Eye Associates of New Mexico
  • Western New York Eye Center
  • Glaucoma Consultants of the Capital Region
  • Orellana Retina Associates, PLLC
  • University Hospitals of Cleveland
  • Comprehensive Opthalmology & Optical Services
  • Clinical Research Source, Inc.
  • Clinical Research Institute of Southern Oregon
  • Northwest Corneal Services
  • Vision Surgery and Laser Center
  • West Hills Vision Center
  • Glaucoma Consultants and Center for Eye Research
  • University Eye Surgeons
  • St. Luke's Eye Institute
  • Eye Clinic of Austin
  • Baylor College of Medicine
  • Surgical Eye Associates, PA
  • Brazosport Eye Institute
  • Axia Research
  • John Moran Eye Center, University of Utah
  • Physicians Research Options, LC
  • Access Eye Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

1

2

3

Arm Description

rebamipide 1%

Rebamipide 2%

placebo

Outcomes

Primary Outcome Measures

fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12

Secondary Outcome Measures

fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26

Full Information

First Posted
September 12, 2005
Last Updated
January 4, 2008
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00201981
Brief Title
Study of Rebamipide Eye Drops to Treat Dry Eye
Official Title
Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Novartis

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
Detailed Description
There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptom.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
dry eye, keratoconjunctivitis sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
740 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
rebamipide 1%
Arm Title
2
Arm Type
Active Comparator
Arm Description
Rebamipide 2%
Arm Title
3
Arm Type
No Intervention
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Intervention Description
OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks OPC as a single drop per eye (approx 50 µL) 4 times per day for 52 weeks
Primary Outcome Measure Information:
Title
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Time Frame
12 week and 26 week
Secondary Outcome Measure Information:
Title
fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
Time Frame
12 week and 26 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must have symptoms of dry eye for a minimum of 6 months must be able to sign and date an informed consent Exclusion Criteria: presence of anterior segment disease glaucoma or ocular hypertension using Restasis use of topically instilled ocular medications during study use of contact lenses history of ocular surgery within 12 months females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception presence of Stevens-Johnson syndrome any anticipated change in medication through-out study concurrent involvement in another study or previous receipt of this drug cannot be safely be weaned off of ocular medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Foulks, MD
Organizational Affiliation
University of Louisville
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Research Center, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Sun Valley Arthritis Center, Ltd.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Pivotel Research Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Hope research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Buena Vista Eye Care Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Radiant Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Sall Eye Research Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701-5653
Country
United States
Facility Name
Radiant Research - Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Scripps Clinic Medical Group, Inc.
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
American Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Eye Clinic of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Healthcare Partners Medical Group
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Centennial Eye Associates
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Corneal Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Western States Clinical Research, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Peter C. Donshik, MDPC
City
Bloomfield
State/Province
Connecticut
ZIP/Postal Code
06002
Country
United States
Facility Name
Opticare Eye Health Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
The Eye Associates
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Radiant Research, Inc. - Lake Worth
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Eye Associates International
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Pinellas Eye Center
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Ft. Lauderdale Eye Institute
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Marvin E. Greenberg, MD PA 7
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
International Eye Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Omni Eye Services
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Kentucky, Department of Ophthamology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
Kentucky Lions Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40222
Country
United States
Facility Name
Gulf Coast Research Associates, Inc.
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Danial Long, MD
City
Gretna
State/Province
Louisiana
ZIP/Postal Code
70056
Country
United States
Facility Name
Lakeview Optical
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Eye Center Northeast
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Krieger Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
The Wilmer Eye Institute
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
New England Eye Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
The Eye Institute - Lahey Clinic North
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Mississippi Eye Associates
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Montana Medical Research, LLC
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Western New York Eye Center
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Glaucoma Consultants of the Capital Region
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Orellana Retina Associates, PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5068
Country
United States
Facility Name
Comprehensive Opthalmology & Optical Services
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Clinical Research Source, Inc.
City
Perryberg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Northwest Corneal Services
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Vision Surgery and Laser Center
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97470
Country
United States
Facility Name
West Hills Vision Center
City
Moon Township
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
Facility Name
Glaucoma Consultants and Center for Eye Research
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
University Eye Surgeons
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37803
Country
United States
Facility Name
St. Luke's Eye Institute
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Eye Clinic of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Surgical Eye Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Brazosport Eye Institute
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Axia Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
John Moran Eye Center, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Physicians Research Options, LC
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Access Eye Research Center
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22405
Country
United States

12. IPD Sharing Statement

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Study of Rebamipide Eye Drops to Treat Dry Eye

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