Exploratory Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01493180
First received: December 13, 2011
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Keratoconjunctival Epithelial Disorder
Drug: OPC-12759 ophthalmic suspension
Drug: Sodium hyaluronate ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Change in the Keratoconjunctival Staining Score From Baseline [ Time Frame: Basekine, 4 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 102
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPC-12759 ophthalmic suspension
OPC-12759 ophthalmic suspension
Drug: OPC-12759 ophthalmic suspension
OPC-12759 ophthalmic suspension 2%
Active Comparator: Sodium hyaluronate ophthalmic solution
Sodium hyaluronate ophthalmic solution
Drug: Sodium hyaluronate ophthalmic solution
Sodium hyaluronate ophthalmic solution 0.1%

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493180

Locations
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, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Eiji Murakami Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01493180     History of Changes
Other Study ID Numbers: 037E-11-002, JapicCTI-111708
Study First Received: December 13, 2011
Results First Received: January 17, 2014
Last Updated: January 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Disease
Pathologic Processes
Pharmaceutical Solutions
Hyaluronic Acid
Rebamipide
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014