Exploratory Study of OPC-12759 Ophthalmic Suspension

Otsuka

Status and phase

Completed

Phase 2

Conditions

Keratoconjunctival Epithelial Disorder

Treatments

Drug: OPC-12759 ophthalmic suspension

Drug: Sodium hyaluronate ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01493180

JapicCTI-111708 (Other Identifier)

037E-11-002

Details and patient eligibility

About

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-12759 is to be assessed.

Enrollment

102 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
Fluorescein corneal staining score of 3 or higher

Exclusion criteria

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.