Status:
COMPLETED
Confirmatory 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 verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.
Eligibility Criteria
Inclusion
- Out patient
- Subjective complaint of dry eye that has been present for minimum 20 months
- Ocular discomfort severity is moderate to severe
- Corneal - conjunctival damage is moderate to severe
- Unanesthetized Schirmer's test score of 5mm/5minutes 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 sicca
- Ocular hypertension 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 procedural medications
- Receipt of any investigational product within 4 months.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00885079
Start Date
May 1 2009
End Date
April 1 2010
Last Update
December 12 2013
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Kyushu region
Kagoshima, Japan
2
Chushikoku region
Matsuyama, Japan
3
Tokai region
Nagoya, Japan
4
Kansai region
Osaka, Japan