- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493180
Exploratory Study of OPC-12759 Ophthalmic Suspension
Exploratory Study of OPC-12759 Ophthalmic Suspension in Patients With Keratoconjunctiva Epithelial Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Hachioji, Japan
- Kanto region
-
Ibaraki, Japan
- Kansai Region
-
Ikoma, Japan
- Kansai Region
-
Kobe, Japan
- Kansai Region
-
Kure, Japan
- Chugoku region
-
Kyoto, Japan
- Kansai Region
-
Nagoya, Japan
- Tokai region
-
Osaka, Japan
- Kansai Region
-
Osakasayama, Japan
- Kansai Region
-
Tokyo, Japan
- Kanto region
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OPC-12759 ophthalmic suspension
|
OPC-12759 ophthalmic suspension 2%
|
Active Comparator: Sodium hyaluronate ophthalmic solution
|
Sodium hyaluronate ophthalmic solution 0.1%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Keratoconjunctival Staining Score From Baseline
Time Frame: 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. |
Basekine, 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Eiji Murakami, Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunologic Factors
- Gastrointestinal Agents
- Protective Agents
- Adjuvants, Immunologic
- Anti-Ulcer Agents
- Antioxidants
- Pharmaceutical Solutions
- Viscosupplements
- Ophthalmic Solutions
- Hyaluronic Acid
- Rebamipide
Other Study ID Numbers
- 037E-11-002
- JapicCTI-111708 (Other Identifier: Japic)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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