Long Term Administration Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00818324
First received: January 4, 2009
Last updated: January 7, 2014
Last verified: January 2014
Results First Received: January 7, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dry Eye Syndromes
Intervention: Drug: OPC-12759 Ophthalmic suspension

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


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
Study First Received: January 4, 2009
Results First Received: January 7, 2014
Last Updated: January 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency