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Dose-Response Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00234078
First received: October 4, 2005
Last updated: September 27, 2007
Last verified: September 2007
History of Changes
  Purpose

The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.


Condition Intervention Phase
Dry Eye Syndromes
 Drug: OPC-12759
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dose-Response Study of OPC-12759 Ophthalmic Suspension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Study Start Date: January 2005
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatient.
  2. Subjective complaint of dry eye that has been present for minimum 20 months.
  3. Primary ocular discomfort severity is moderate to severe.
  4. Corneal - conjunctival damage is moderate to severe.
  5. Unanesthetized Schirmer's test score of 7mm/5minutes or less.
  6. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

  1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca.
  2. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
  3. Anticipated use of contact lens during the study.
  4. Any history of ocular surgery within 12 months.
  5. Female patients who are pregnant, possibly pregnant or breast feeding;
  6. Known hypersensitivity to any component of the study drug or procedural medications.
  7. Receipt of any investigational product within 4 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234078

Locations
Japan
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Satoshi Oshima Dermatologicals & Ophthalmologicals Division
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234078     History of Changes
Other Study ID Numbers: 037E-04-002, JapicCTI-050040
Study First Received: October 4, 2005
Last Updated: September 27, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
OPC-12759
Dry eye syndromes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Rebamipide
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013