Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
290 participants
INTERVENTIONAL
2005-01-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.5% OPC-12759
0.5% OPC-12759 (rebamipide) ophthalmic suspension
0.5% OPC-12759
1% OPC-12759
1% OPC-12759 (rebamipide) ophthalmic suspension
1% OPC-12759
2% OPC-12759
2% OPC-12759 (rebamipide) ophthalmic suspension
2% OPC-12759
placebo
placebo of OPC-12759 (rebamipide) ophthalmic suspension
placebo
Interventions
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0.5% OPC-12759
1% OPC-12759
2% OPC-12759
placebo
Eligibility Criteria
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Inclusion Criteria
2. Subjective complaint of dry eye that has been present for minimum 20 months.
3. Primary ocular discomfort severity is moderate to severe.
4. Corneal - conjunctival damage is moderate to severe.
5. Unanesthetized Schirmer's test score of 7mm/5minutes or less.
6. Best corrected visual acuity of 0.2 or better in both eyes.
Exclusion Criteria
2. Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
3. Anticipated use of contact lens during the study.
4. Any history of ocular surgery within 12 months.
5. Female patients who are pregnant, possibly pregnant or breast feeding;
6. Known hypersensitivity to any component of the study drug or procedural medications.
7. Receipt of any investigational product within 4 months.
20 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Satoshi Oshima
Role: STUDY_DIRECTOR
Dermatologicals & Ophthalmologicals Division
Locations
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Otsuka Pharmaceutical Co., Ltd.
Tokyo, , Japan
Countries
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Other Identifiers
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JapicCTI-050040
Identifier Type: -
Identifier Source: secondary_id
037E-04-002
Identifier Type: -
Identifier Source: org_study_id
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