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Long Term Administration Study of OPC-12759 Ophthalmic Suspension

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ClinicalTrials.gov Identifier: NCT00818324
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: OPC-12759 Ophthalmic suspension Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
Study Start Date : January 2009
Primary Completion Date : September 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: OPC-12759 Ophthalmic suspension
Instillation, 4times/day
Drug: OPC-12759 Ophthalmic suspension
Instillation,4times/day,for 52weeks


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ]
    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:
  1. Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ]
    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).


Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 7, 2009    Key Record Dates
Results First Posted: February 26, 2014
Last Update Posted: February 26, 2014
Last Verified: January 2014

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