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Confirmatory Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00885079
First received: April 19, 2009
Last updated: August 3, 2010
Last verified: August 2010
History of Changes
  Purpose

The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.


Condition Intervention Phase
Dry Eye Syndromes
 Drug: OPC-12759 Ophthalmic suspension
Drug: Hyalein Mini Ophthalmic solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Fluorescein corneal staining score and Lisamingreen conjunctive staining score [ Time Frame: Weeks2, 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.
Instillation,4 times/day for 4 weeks
 Drug: OPC-12759 Ophthalmic suspension
OPC-12759 Ophthalmic suspension 2%
Active Comparator: 2.
Instillation,6 times/day for 4 weeks
 Drug: Hyalein Mini Ophthalmic solution
Hyalein Mini Ophthalmic solution 0.1%

  Eligibility

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

Inclusion Criteria:

  1. Out patient
  2. Subjective complaint of dry eye that has been present for minimum 20 months
  3. Ocular discomfort severity is moderate to severe
  4. Corneal - conjunctival damage is moderate to severe
  5. Unanesthetized Schirmer's test score of 5mm/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. Ocular hypertension patient or glaucoma patient with ophthalmic solution
  3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
  4. Anticipated use of contact lens during the study
  5. Patient with punctal plug
  6. Any history of ocular surgery within 12 months
  7. Female patients who are pregnant,possibly pregnant or breast feeding
  8. Known hypersensitivity to any component of the study drug or procedural medications
  9. Receipt of any investigational product within 4 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885079

Locations
Japan
Kyushu region
Kagoshima, Japan
Chushikoku region
Matsuyama, Japan
Tokai region
Nagoya, Japan
Kansai region
Osaka, Japan
Kanto region
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Chair: Eiji Murakami OPCJ-DDO
  More Information

No publications provided

Responsible Party: Eiji Murakami/Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00885079     History of Changes
Other Study ID Numbers: 037E-08-001
Study First Received: April 19, 2009
Last Updated: August 3, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

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 19, 2013