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Long Term Administration Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818324
First Posted: January 7, 2009
Last Update Posted: February 26, 2014
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:
Otsuka Pharmaceutical Co., Ltd.
Results First Submitted: January 7, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Dry Eye Syndromes
Intervention: Drug: OPC-12759 Ophthalmic suspension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
2% Rebamipide Group 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks

Participant Flow:   Overall Study
    2% Rebamipide Group
STARTED   154 
COMPLETED   127 
NOT COMPLETED   27 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
2% Rebamipide Group 2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks

Baseline Measures
   2% Rebamipide Group 
Overall Participants Analyzed 
[Units: Participants]
 154 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.3  (14.7) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   90 
>=65 years   64 
Gender 
[Units: Participants]
 
Female   139 
Male   15 
Region of Enrollment 
[Units: Participants]
 
Japan   154 


  Outcome Measures
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1.  Primary:   Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score   [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ]

2.  Other Pre-specified:   Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score   [ Time Frame: Baseline, Week2, Week4, Week28, Week52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
phone: +81-3-6361-7366



Responsible Party: Eiji Murakami/Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00818324     History of Changes
Other Study ID Numbers: 037E-08-002
First Submitted: January 4, 2009
First Posted: January 7, 2009
Results First Submitted: January 7, 2014
Results First Posted: February 26, 2014
Last Update Posted: February 26, 2014