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Safety Study of OPC-12759 Ophthalmic Solution

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01471093
First Posted: November 11, 2011
Last Update Posted: February 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
  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
Intervention Model: Crossover Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01471093     History of Changes
Other Study ID Numbers: 037E-11-004
JapicCTI-111674 ( Other Identifier: Japic )
First Submitted: November 3, 2011
First Posted: November 11, 2011
Last Update Posted: February 27, 2012
Last Verified: February 2012

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


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