Status:
COMPLETED
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- Out patient;
- Ocular discomfort severity is moderate to severe;
- Corneal-conjunctival damage is moderate to severe;
- Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
- Best corrected visual acuity of 0.2 or better in both eyes.
Exclusion
- Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
- Ocular hypertention patient or glaucoma patient with ophthalmic solution;
- Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
- Anticipated use of contact lens during the study;
- Patient with punctal plug;
- Any history of ocular surgery within 12 months;
- Female patients who are pregnant, possibly pregnant or breast feeding;
- Known hypersensitivity to any component of the study drug or procedual medications;
- Receipt of any investigational product within 4 months.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00818324
Start Date
January 1 2009
End Date
January 1 2011
Last Update
February 26 2014
Active Locations (5)
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1
Kansai Region, Japan
2
Kanto Region, Japan
3
Kyushu Region, Japan
4
Tohoku Region, Japan