Exploratory Study of OPC-12759 Ophthalmic Suspension

Keratoconjunctival Epithelial Disorder Clinical Trial

Official title:

Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493180
• Other study ID #: 037E-11-002
• Secondary ID: JapicCTI-111708
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2011
• Last updated: February 19, 2015
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2015
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconjunctival Epithelial Disorder

Intervention

Drug:
• OPC-12759 ophthalmic suspension
OPC-12759 ophthalmic suspension 2%
• Sodium hyaluronate ophthalmic solution
Sodium hyaluronate ophthalmic solution 0.1%

Locations

Country	Name	City	State
Japan	Kanto region	Hachioji
Japan	Kansai region	Ibaraki
Japan	Kansai region	Ikoma
Japan	Kansai Region	Kobe
Japan	Chugoku region	Kure
Japan	Kansai region	Kyoto
Japan	Tokai region	Nagoya
Japan	Kansai region	Osaka
Japan	Kansai region	Osakasayama
Japan	Kanto region	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Keratoconjunctival Staining Score From Baseline	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.	Basekine, 4 weeks	No