Study of Rebamipide Eye Drops to Treat Dry Eye - Full Text View

Sponsors and Collaborators:	Otsuka Pharmaceutical Development & Commercialization, Inc. Novartis
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00201981

Purpose

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	Intervention	Phase
Keratoconjunctivitis Sicca	Drug: Rebamipide	Phase III

Drug Information available for: Rebamipide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	740
Study Start Date:	May 2004
Study Completion Date:	February 2007

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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
3: No Intervention placebo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201981

Show 63 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Novartis

Investigators

Study Chair:

Gary Foulks, MD

University of Louisville

More Information

Publications:

Yamasaki K, Ishiyama H, Imaizumi T, Kanbe T, Yabuuchi Y. Effect of OPC-12759, a novel antiulcer agent, on chronic and acute experimental gastric ulcer, and gastric secretion in rats. Jpn J Pharmacol. 1989 Apr;49(4):441-8.

Yamasaki K, Kanbe T, Chijiwa T, Ishiyama H, Morita S. Gastric mucosal protection by OPC-12759, a novel antiulcer compound, in the rat. Eur J Pharmacol. 1987 Oct 6;142(1):23-9.

Yoshikawa T, Naito Y, Tanigawa T, Kondo M. Free radical scavenging activity of the novel anti-ulcer agent rebamipide studied by electron spin resonance. Arzneimittelforschung. 1993 Mar;43(3):363-6.

Yoshikawa T, Naito Y, Nakamura S, Nishimura S, Kaneko T, Iinuma S, Takahashi S, Kondo M, Yamasaki K. Effect of rebamipide on lipid peroxidation and gastric mucosal injury induced by indometacin in rats. Arzneimittelforschung. 1993 Dec;43(12):1327-30.

Yamasaki K, Kanbe T, Chijiwa T, Ishiyama H, Morita S. Gastric mucosal protection by OPC-12759, a novel antiulcer compound, in the rat. Eur J Pharmacol. 1987 Oct 6;142(1):23-9.

Yamasaki K, Ishiyama H, Imaizumi T, Kanbe T, Yabuuchi Y. Effect of OPC-12759, a novel antiulcer agent, on chronic and acute experimental gastric ulcer, and gastric secretion in rats. Jpn J Pharmacol. 1989 Apr;49(4):441-8.

Garcher C, Bron A, Baudouin C, Bildstein L, Bara J. CA 19-9 ELISA test: a new method for studying mucus changes in tears. Br J Ophthalmol. 1998 Jan;82(1):88-90.

Danjo Y, Watanabe H, Tisdale AS, George M, Tsumura T, Abelson MB, Gipson IK. Alteration of mucin in human conjunctival epithelia in dry eye. Invest Ophthalmol Vis Sci. 1998 Dec;39(13):2602-9.

Pflugfelder SC, Tseng SC, Yoshino K, Monroy D, Felix C, Reis BL. Correlation of goblet cell density and mucosal epithelial membrane mucin expression with rose bengal staining in patients with ocular irritation. Ophthalmology. 1997 Feb;104(2):223-35.

Kinoshita S, Kiorpes TC, Friend J, Thoft RA. Goblet cell density in ocular surface disease. A better indicator than tear mucin. Arch Ophthalmol. 1983 Aug;101(8):1284-7.

Rivas L, Oroza MA, Perez-Esteban A, Murube-del-Castillo J. Morphological changes in ocular surface in dry eyes and other disorders by impression cytology. Graefes Arch Clin Exp Ophthalmol. 1992;230(4):329-34.

Nelson JD, Wright JC. Conjunctival goblet cell densities in ocular surface disease. Arch Ophthalmol. 1984 Jul;102(7):1049-51.

Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.

Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. Review. No abstract available.

Gail M, Simon R. Testing for qualitative interactions between treatment effects and patient subsets. Biometrics. 1985 Jun;41(2):361-72.

Davis CS, Chung Y. Randomization model methods for evaluating treatment efficacy in multicenter clinical trials. Biometrics. 1995 Sep;51(3):1163-74.

Responsible Party:	Otsuka Pharmaceutical Development & Commercialization ( Juan Guzman, MD/ Sr. Director, Global Clinical Development )
Study ID Numbers:	37E-03-202
Study First Received:	September 12, 2005
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00201981
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

dry eye
keratoconjunctivitis sicca

Study placed in the following topic categories:

Corneal Diseases
Keratoconjunctivitis sicca
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Conjunctivitis
Tetrahydrozoline

Keratoconjunctivitis
Rebamipide
Conjunctival Diseases
Xerophthalmia
Keratitis
Keratoconjunctivitis Sicca

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2009