Exploratory Study of OPC-12759 Ophthalmic Suspension

Phase 2

Completed

• Conditions: Keratoconjunctival Epithelial Disorder
• Interventions: Drug: Sodium hyaluronate ophthalmic solution; Drug: OPC-12759 ophthalmic suspension

• Registration Number: NCT01493180
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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-12759 is to be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Results First Submitted: 2014-01-17
• Results First Submitted QC: 2014-01-17
• Results First Posted: 2014-03-03
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium hyaluronate ophthalmic solution	Sodium hyaluronate ophthalmic solution	Sodium hyaluronate ophthalmic solution
OPC-12759 ophthalmic suspension	OPC-12759 ophthalmic suspension	OPC-12759 ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Change in the Keratoconjunctival Staining Score From Baseline	Basekine, 4 weeks	Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better.; The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test.

Trial Locations

Locations (5)

Kansai Region; 🇯🇵 Kobe, Japan

Chugoku region; 🇯🇵 Kure, Japan

Tokai region; 🇯🇵 Nagoya, Japan

Kansai region; 🇯🇵 Osaka, Japan

Kanto region; 🇯🇵 Tokyo, Japan