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Long Term Administration Study of OPC-12759 Ophthalmic Suspension
This study is currently recruiting participants.
Verified by Otsuka Pharmaceutical Co., Ltd., January 2009
Sponsored by: Otsuka Pharmaceutical Co., Ltd.
Information provided by: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00818324
  Purpose

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients


Condition Intervention Phase
Dry Eye Syndromes
Drug: OPC-12759 Ophthalmic suspension
Phase III

Drug Information available for: Rebamipide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

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

Primary Outcome Measures:
  • Fluorescein corneal staining score [ Time Frame: Weeks2,4,8,12,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lisamingreen conjunctive staining score [ Time Frame: Weeks2,4,8,12,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 153
Study Start Date: January 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
OPC-12759 Ophthalmic suspension: Experimental
Instillation, 4times/day
Drug: OPC-12759 Ophthalmic suspension
Instillation,4times/day,for 52weeks

  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. Ocular discomfort severity is moderate to severe;
  3. Corneal-conjunctival damage is moderate to severe;
  4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
  5. 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 scicca;
  2. Ocular hypertention 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 procedual medications;
  9. Receipt of any investigational product within 4 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818324

Contacts
Contact: Drug Information Center opc_ctr@otsuka.jp

Locations
Japan
Recruiting
Tohoku region, Japan
Recruiting
Kanto region, Japan
Recruiting
Tokai region, Japan
Recruiting
Kansai region, Japan
Recruiting
Kyushu region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Chair: Eiji Murakami OPCJ-DDO
  More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd. ( Eiji Murakami/Director of Division of Dermatologicals and Ophthalmologicals )
Study ID Numbers: 037E-08-002
Study First Received: January 4, 2009
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00818324  
Health Authority: Japan: Ministry of Health, Labor and Welfare;   Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Rebamipide

Additional relevant MeSH terms:
Antioxidants
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009