Study of Rebamipide Eye Drops to Treat Dry Eye

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00201955

Collaborator

Novartis (Industry)

740

Enrollment

Locations

Duration (Months)

12.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: Rebamipide	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

May 1, 2004

Study Completion Date :

Jul 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harold Helms, MD	Birmingham	Alabama	United States	35205
2	Michael Bernstein, MD	Birmingham	Alabama	United States	35216
3	I Care! Eye Care!	Flagstaff	Arizona	United States	860001
4	Harvey and Bernice Jones Eye Institute	Little Rock	Arkansas	United States	72205
5	United Medical Research Institute	Inglewood	California	United States	90301
6	Benchmark Research	San Francisco	California	United States	94102
7	Southern California Clinical Research, Inc.	San Marino	California	United States	91108
8	Colorado Eye Associates, PC	Colorado Springs	Colorado	United States	80907
9	Danbury Eye Physicians and Surgeons, P.C.	Danbury	Connecticut	United States	06810-4005
10	Florida Ophthalmic Institute	Gainesville	Florida	United States	32605-3192
11	Florida Wellcare Alliance, L.C.	Inverness	Florida	United States	34452
12	Shettle Eye Center	Largo	Florida	United States	33770
13	Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
14	Tukio Institute for Clinical Research	North Miami Beach	Florida	United States	33169
15	Magnolia Research Group, Inc.	Ocala	Florida	United States	34471
16	Radiant Research - West Palm Beach	West Palm Beach	Florida	United States	33407
17	Vision Incorporated	Savannah	Georgia	United States	31406
18	Welborn Clinic	Evansville	Indiana	United States	47714
19	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
20	Wichita Clinic, PA	Wichita	Kansas	United States	67208
21	Taustine Eye Center	Louisville	Kentucky	United States	40217
22	Bossier Optical, Inc.	Bossier	Louisiana	United States	71111
23	Stevenson Medical Surgical Eye Center	New Orleans	Louisiana	United States	70119
24	Family Eye Centers	New Orleans	Louisiana	United States	70127
25	Ophthalmic Research Associates, Inc.	N. Andover	Massachusetts	United States	01845
26	Minnesota Eye Associates	Minneapolis	Minnesota	United States	55404
27	Depremont Eye Specialists	Gulfport	Mississippi	United States	39507
28	Opthalmology Associates	Creve Coeur	Missouri	United States	63141
29	Clinical Research Laboratories	Piscataway	New Jersey	United States	08854
30	Ophthalmology Associates	Princeton	New Jersey	United States	08540
31	Eye Care Associates	Bethpage	New York	United States	11021
32	Ophthmalmic Consultants of Long Island	Lynbrook	New York	United States	11563
33	Mt. Sinai Medical Center School of Medicine	New York	New York	United States	10029
34	Rochester Ophthalmological Group	Rochester	New York	United States	14618
35	Ophthalmic Consultants of Long Island	Rockville Center	New York	United States	11570
36	Ophthalmic Consultants of Long Island	Valley Stream	New York	United States	11581
37	Western Wake Eye Center, P.A.	Cary	North Carolina	United States	27511
38	Southeast Clinical Research Associates	Charlotte	North Carolina	United States	28210
39	Horizon Eye Care - Clinical Research Dept.	Charlotte	North Carolina	United States	28211
40	Cornerstone Research Care	High Point	North Carolina	United States	27262
41	Carolina Eye Associates	Southern Pines	North Carolina	United States	28387
42	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
43	Comprehensive Opthalmology & Optical Services	Cleveland	Ohio	United States	44115
44	Bend Medical Clinic	Bend	Oregon	United States	97701
45	Medical Eye Center	Medford	Oregon	United States	97504
46	Valley Clinical Research Center	Easton	Pennsylvania	United States	18045
47	Philadelphia Eye Associates	Philadelphia	Pennsylvania	United States	19148
48	Glaucome-Cataract Consultants	Pittsburgh	Pennsylvania	United States	15243
49	University of Pittsburg Eye and Ear Institute	Pittsburg	Pennsylvania	United States	15233
50	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
51	Total Eye Care, P.A.	Memphis	Tennessee	United States	38119
52	Corona Research Consultants, Inc.	El Paso	Texas	United States	79904
53	The University of Texas Medical Branch	Galveston	Texas	United States	77555
54	Physician Research Network	Houston	Texas	United States	77002
55		Houston	Texas	United States	77002
56	Medical Center Ophthalmology	Houston	Texas	United States	77030
57	Houston Eye Associates	Houston	Texas	United States	77125
58	Sun Research Institute	San Antonio	Texas	United States	78205
59	Eye Clinic of South Texas	San Antonio	Texas	United States	78209
60	Advanced Healthcare Clinical Research Center	Milwaukee	Wisconsin	United States	21209