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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
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

  • Harold Helms, MD
  • Michael Bernstein, MD
  • I Care! Eye Care!
  • Harvey and Bernice Jones Eye Institute
  • United Medical Research Institute
  • Benchmark Research
  • Southern California Clinical Research, Inc.
  • Colorado Eye Associates, PC
  • Danbury Eye Physicians and Surgeons, P.C.
  • Florida Ophthalmic Institute
  • Florida Wellcare Alliance, L.C.
  • Shettle Eye Center
  • Suncoast Clinical Research, Inc.
  • Tukio Institute for Clinical Research
  • Magnolia Research Group, Inc.
  • Radiant Research - West Palm Beach
  • Vision Incorporated
  • Welborn Clinic
  • Heartland Research Associates, LLC
  • Wichita Clinic, PA
  • Taustine Eye Center
  • Bossier Optical, Inc.
  • Stevenson Medical Surgical Eye Center
  • Family Eye Centers
  • Ophthalmic Research Associates, Inc.
  • Minnesota Eye Associates
  • Depremont Eye Specialists
  • Opthalmology Associates
  • Clinical Research Laboratories
  • Ophthalmology Associates
  • Eye Care Associates
  • Ophthmalmic Consultants of Long Island
  • Mt. Sinai Medical Center School of Medicine
  • Rochester Ophthalmological Group
  • Ophthalmic Consultants of Long Island
  • Ophthalmic Consultants of Long Island
  • Western Wake Eye Center, P.A.
  • Southeast Clinical Research Associates
  • Horizon Eye Care - Clinical Research Dept.
  • Cornerstone Research Care
  • Carolina Eye Associates
  • Cincinnati Eye Institute
  • Comprehensive Opthalmology & Optical Services
  • Bend Medical Clinic
  • Medical Eye Center
  • Valley Clinical Research Center
  • Philadelphia Eye Associates
  • Glaucome-Cataract Consultants
  • University of Pittsburg Eye and Ear Institute
  • Black Hills Regional Eye Institute
  • Total Eye Care, P.A.
  • Corona Research Consultants, Inc.
  • The University of Texas Medical Branch
  • Physician Research Network
  • Medical Center Ophthalmology
  • Houston Eye Associates
  • Sun Research Institute
  • Eye Clinic of South Texas
  • Advanced Healthcare Clinical Research Center

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
October 31, 2006
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00201955
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, 26 Week Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

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 symptoms.

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
Double
Allocation
Randomized
Enrollment
740 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rebamipide
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
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

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
Facility Information:
Facility Name
Harold Helms, MD
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Michael Bernstein, MD
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
I Care! Eye Care!
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
860001
Country
United States
Facility Name
Harvey and Bernice Jones Eye Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Benchmark Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Southern California Clinical Research, Inc.
City
San Marino
State/Province
California
ZIP/Postal Code
91108
Country
United States
Facility Name
Colorado Eye Associates, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Danbury Eye Physicians and Surgeons, P.C.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810-4005
Country
United States
Facility Name
Florida Ophthalmic Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605-3192
Country
United States
Facility Name
Florida Wellcare Alliance, L.C.
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Shettle Eye Center
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
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
Tukio Institute for Clinical Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Magnolia Research Group, Inc.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Radiant Research - West Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Vision Incorporated
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Wichita Clinic, PA
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Bossier Optical, Inc.
City
Bossier
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Stevenson Medical Surgical Eye Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Family Eye Centers
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70127
Country
United States
Facility Name
Ophthalmic Research Associates, Inc.
City
N. Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
Facility Name
Minnesota Eye Associates
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Depremont Eye Specialists
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39507
Country
United States
Facility Name
Opthalmology Associates
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Laboratories
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Ophthalmology Associates
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Eye Care Associates
City
Bethpage
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Ophthmalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Mt. Sinai Medical Center School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Rochester Ophthalmological Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Center
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11581
Country
United States
Facility Name
Western Wake Eye Center, P.A.
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Southeast Clinical Research Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Horizon Eye Care - Clinical Research Dept.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Cornerstone Research Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Carolina Eye Associates
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Comprehensive Opthalmology & Optical Services
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Bend Medical Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Medical Eye Center
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Valley Clinical Research Center
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Philadelphia Eye Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Glaucome-Cataract Consultants
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
University of Pittsburg Eye and Ear Institute
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15233
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
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Corona Research Consultants, Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79904
Country
United States
Facility Name
The University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Physician Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Medical Center Ophthalmology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77125
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Eye Clinic of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Advanced Healthcare Clinical Research Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
21209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Rebamipide Eye Drops to Treat Dry Eye

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