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Confirmatory Study of OPC-12759 Ophthalmic Suspension

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ClinicalTrials.gov Identifier: NCT00885079
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : December 12, 2013
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
Study Start Date : May 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Rebamipide
Instillation,4 times/day for 4 weeks
 Drug: OPC-12759 Ophthalmic suspension
OPC-12759 Ophthalmic suspension 2%
Active Comparator: Hyaluronate
Instillation,6 times/day for 4 weeks
 Drug: Hyalein Mini Ophthalmic solution
Hyalein Mini Ophthalmic solution 0.1%


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fluorescein Corneal Staining (FCS) Score From Baseline [ Time Frame: Baseline, Weeks4 ]
    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. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups

  2. Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline [ Time Frame: Baseline, Weeks4 ]
    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 sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00885079


Locations
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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
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Study Chair: Eiji Murakami OPCJ-DDO
More Information
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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00885079    
Other Study ID Numbers: 037E-08-001
First Posted: April 21, 2009    Key Record Dates
Results First Posted: December 12, 2013
Last Update Posted: December 12, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Rebamipide
 Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors