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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014