Study of Rebamipide Eye Drops to Treat Dry Eye

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00201981

Collaborator

Novartis (Industry)

740

Enrollment

Locations

Arms

33.1

Duration (Months)

11.7

Patients Per Site

0.4

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 symptom.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

740 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

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, 52 Week Study

Study Start Date :

May 1, 2004

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 rebamipide 1%	Drug: Rebamipide 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
Active Comparator: 2 Rebamipide 2%	Drug: Rebamipide 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
No Intervention: 3 placebo

Arm

Intervention/Treatment

Active Comparator: 1

rebamipide 1%

Drug: Rebamipide

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

Active Comparator: 2

Rebamipide 2%

Drug: Rebamipide

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

No Intervention: 3

placebo

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 [12 week and 26 week]

Secondary Outcome Measures

fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26 [12 week and 26 week]

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	Alabama Research Center, LLC	Birmingham	Alabama	United States	35209
2	Sun Valley Arthritis Center, Ltd.	Glendale	Arizona	United States	85308
3	Pivotel Research Center	Peoria	Arizona	United States	85381
4	Hope research Institute	Phoenix	Arizona	United States	85006
5	Buena Vista Eye Care Center	Phoenix	Arizona	United States	85012
6	Radiant Research	Scottsdale	Arizona	United States	85251
7	Sall Eye Research Center	Artesia	California	United States	90701-5653
8	Radiant Research - Irvine	Irvine	California	United States	92618
9	Scripps Clinic Medical Group, Inc.	La Jolla	California	United States	92037
10	American Eye Institute	Los Angeles	California	United States	90048
11	Eye Clinic of San Diego	San Diego	California	United States	92103
12	Healthcare Partners Medical Group	Torrance	California	United States	90503
13	Centennial Eye Associates	Centennial	Colorado	United States	80112
14	Corneal Consultants of Colorado	Littleton	Colorado	United States	80120
15	Western States Clinical Research, Inc.	Wheat Ridge	Colorado	United States	80033
16	Peter C. Donshik, MDPC	Bloomfield	Connecticut	United States	06002
17	Opticare Eye Health Center	Waterbury	Connecticut	United States	06708
18	The Eye Associates	Bradenton	Florida	United States	34209
19	Hernando Eye Institute	Brooksville	Florida	United States	34613
20	Radiant Research, Inc. - Lake Worth	Lake Worth	Florida	United States	33461
21	Suncoast Clinical Research, Inc.	New Port Richey	Florida	United States	34652
22	Eye Associates International	Ormond Beach	Florida	United States	32174
23	Pinellas Eye Center	Pinellas Park	Florida	United States	33781
24	Ft. Lauderdale Eye Institute	Sunrise	Florida	United States	33351
25	Marvin E. Greenberg, MD PA 7	Tamarac	Florida	United States	33321
26	Clinical Research of West Florida, Inc.	Tampa	Florida	United States	33603
27	International Eye Center	Tampa	Florida	United States	33603
28	Omni Eye Services	Atlanta	Georgia	United States	30342
29	University of Kentucky, Department of Ophthamology	Lexington	Kentucky	United States	40536-0293
30	Kentucky Lions Eye Center	Louisville	Kentucky	United States	40222
31	Gulf Coast Research Associates, Inc.	Baton Rouge	Louisiana	United States	70808
32	Danial Long, MD	Gretna	Louisiana	United States	70056
33	Lakeview Optical	New Orleans	Louisiana	United States	70124
34	Eye Center Northeast	Bangor	Maine	United States	04401
35	Krieger Eye Institute	Baltimore	Maryland	United States	21215
36	The Wilmer Eye Institute	Lutherville	Maryland	United States	21093
37	New England Eye Center	Boston	Massachusetts	United States	02111
38	The Eye Institute - Lahey Clinic North	Peabody	Massachusetts	United States	01960
39	Mississippi Eye Associates	Ocean Springs	Mississippi	United States	39564
40	Montana Medical Research, LLC	Missoula	Montana	United States	59804
41	Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89104
42	Eye Associates of New Mexico	Albuquerque	New Mexico	United States	87109
43	Western New York Eye Center	Orchard Park	New York	United States	14127
44	Glaucoma Consultants of the Capital Region	Slingerlands	New York	United States	12159
45	Orellana Retina Associates, PLLC	Raleigh	North Carolina	United States	27612
46	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106-5068
47	Comprehensive Opthalmology & Optical Services	Cleveland	Ohio	United States	44115
48	Clinical Research Source, Inc.	Perryberg	Ohio	United States	43551
49	Clinical Research Institute of Southern Oregon	Medford	Oregon	United States	97504
50	Northwest Corneal Services	Portland	Oregon	United States	97223
51	Vision Surgery and Laser Center	Roseburg	Oregon	United States	97470
52	West Hills Vision Center	Moon Township	Pennsylvania	United States	15108
53	Glaucoma Consultants and Center for Eye Research	Mt. Pleasant	South Carolina	United States	29464
54	University Eye Surgeons	Maryville	Tennessee	United States	37803
55	St. Luke's Eye Institute	Amarillo	Texas	United States	79106
56	Eye Clinic of Austin	Austin	Texas	United States	78731
57	Baylor College of Medicine	Houston	Texas	United States	77030
58	Surgical Eye Associates, PA	Houston	Texas	United States	77055
59	Brazosport Eye Institute	Lake Jackson	Texas	United States	77566
60	Axia Research	Salt Lake City	Utah	United States	84107
61	John Moran Eye Center, University of Utah	Salt Lake City	Utah	United States	84132
62	Physicians Research Options, LC	Sandy	Utah	United States	84070
63	Access Eye Research Center	Fredericksburg	Virginia	United States	22405