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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
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Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00818324 |
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 |
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 |
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
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Drug: OPC-12759 Ophthalmic suspension
Instillation,4times/day,for 52weeks
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Drug Information Center | opc_ctr@otsuka.jp |
Japan | |
Recruiting | |
Tohoku region, Japan | |
Recruiting | |
Kanto region, Japan | |
Recruiting | |
Tokai region, Japan | |
Recruiting | |
Kansai region, Japan | |
Recruiting | |
Kyushu region, Japan |
Study Chair: | Eiji Murakami | OPCJ-DDO |
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 |
Eye Diseases Lacrimal Apparatus Diseases Dry Eye Syndromes Rebamipide |
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Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Protective Agents Pharmacologic Actions |