Status:
COMPLETED
Dose-response Study of OPC-12759 Ophthalmic Suspension
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients.
Eligibility Criteria
Inclusion
- Outpatient.
- Subjective complaint of dry eye that has been present for minimum 20 months.
- Primary ocular discomfort severity is moderate to severe.
- Corneal - conjunctival damage is moderate to severe.
- Unanesthetized Schirmer's test score of 7mm/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.
- Anticipated use of any topically-instilled ocular medications or patients with cannot discontinue the use during the study.
- Anticipated use of contact lens during the study.
- 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 :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00234078
Start Date
January 1 2005
End Date
March 1 2007
Last Update
February 28 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan