Long Term Administration Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00818324
First received: January 4, 2009
Last updated: January 7, 2014
Last verified: January 2014
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ] [ Designated as safety issue: No ]
    FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).


Other Outcome Measures:
  • Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ] [ Designated as safety issue: No ]
    LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).


Enrollment: 154
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-12759 Ophthalmic suspension
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

Locations
Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Tohoku region, Japan
Tokai region, 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: NCT00818324     History of Changes
Other Study ID Numbers: 037E-08-002
Study First Received: January 4, 2009
Results First Received: January 7, 2014
Last Updated: January 7, 2014
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 April 16, 2014