Status:
COMPLETED
Exploratory Study of OPC-12759 Ophthalmic Suspension
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Keratoconjunctival Epithelial Disorder
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of OPC-12759 ophthalmic suspension for patients with keratoconjunctival epithelial disorder compared with sodium hyaluronate. Also, safety of OPC-...
Eligibility Criteria
Inclusion
- Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
- Fluorescein corneal staining score of 3 or higher
Exclusion
- Active ocular infection
- Vernal keratoconjunctivitis
- Recurrent corneal erosion
- Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
- Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
- Anticipated use of contact lens during the study.
- Insertion of punctal plug or fall out of punctal plug within 3 months
- Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
- Receipt of any investigational product within 4 months.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01493180
Start Date
December 1 2011
End Date
December 1 2012
Last Update
March 10 2015
Active Locations (10)
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1
Kanto region
Hachiōji, Japan
2
Kansai region
Ibaraki, Japan
3
Kansai region
Ikoma, Japan
4
Kansai Region
Kobe, Japan