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Safety Study of OPC-12759 Ophthalmic Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01471093
First received: November 3, 2011
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.


Condition Intervention Phase
Dry Eye Syndromes
 Drug: OPC-12759 Ophthalmic solution
Drug: OPC-12759 Ophthalmic suspension
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Score change on severity of blurred vision [ Time Frame: Days 1,2 ] [ Designated as safety issue: Yes ]
  • Score change on severity of dysgeusia [ Time Frame: Days 1,2 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solution
A single dose of OPC-12759 Ophthalmic solution for two-day treatment
 Drug: OPC-12759 Ophthalmic solution
2％ OPC-12759 Ophthalmic solution
Active Comparator: Suspension
A single dose of OPC-12759 Ophthalmic suspension for two-day treatment
 Drug: OPC-12759 Ophthalmic suspension
2％ OPC-12759 Ophthalmic suspension

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2

Exclusion Criteria:

  1. Presence of ocular disorder
  2. Intraocular pressure of 21mmHg or higher
  3. Corrected visual acuity of less than 1.0
  4. Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
  5. History of refractive surgery
  6. History of other ocular surgeries within 12 months
  7. Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471093

Locations
Japan
Kansai region
Osaka, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Chair: Eiji Murakami Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01471093     History of Changes
Other Study ID Numbers: 037E-11-004, JapicCTI-111674
Study First Received: November 3, 2011
Last Updated: February 23, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Rebamipide
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013