Exploratory Study of OPC-12759 Ophthalmic Suspension

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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-12759 is to be assessed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Hyaluronic Acid; Ophthalmic Solutions; Pharmaceutical Solutions; Rebamipide

Criteria

Inclusion Criteria:

1. Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect

2. Fluorescein corneal staining score of 3 or higher

Exclusion Criteria:

1. Active ocular infection

2. Vernal keratoconjunctivitis

3. Recurrent corneal erosion

4. Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva

5. 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.

6. Anticipated use of contact lens during the study.

7. Insertion of punctal plug or fall out of punctal plug within 3 months

8. Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.

9. Receipt of any investigational product within 4 months.