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Safety Study of OPC-12759 Ophthalmic Solution

This study has been completed.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd. Identifier:
First received: November 3, 2011
Last updated: February 23, 2012
Last verified: February 2012
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
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects

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 ]
  • Score change on severity of dysgeusia [ Time Frame: Days 1,2 ]

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


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01471093

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

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT01471093     History of Changes
Other Study ID Numbers: 037E-11-004
JapicCTI-111674 ( Other Identifier: Japic )
Study First Received: November 3, 2011
Last Updated: February 23, 2012

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors processed this record on May 25, 2017