Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00475319
First received: May 16, 2007
Last updated: June 4, 2013
Last verified: May 2013
Results First Received: January 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Dry Eye Syndromes
Interventions: Drug: placebo
Drug: 1% OPC-12759 ophthalmic suspension
Drug: 2% 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
Subjects were recruited in Japan between 2007 and 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant flow results are based on the safety set.

Reporting Groups
  Description
1% OPC-12759 Groups 1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
2% OPC-12759 Groups 2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
Placebo 0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks

Participant Flow:   Overall Study
    1% OPC-12759 Groups     2% OPC-12759 Groups     Placebo  
STARTED     103     102     103  
COMPLETED     101     101     99  
NOT COMPLETED     2     1     4  



  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.
No text entered.

Reporting Groups
  Description
1% OPC-12759 Groups 1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
2% OPC-12759 Groups 2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
Placebo 0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
Total Total of all reporting groups

Baseline Measures
    1% OPC-12759 Groups     2% OPC-12759 Groups     Placebo     Total  
Number of Participants  
[units: participants]
  103     102     103     308  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     70     61     62     193  
>=65 years     33     41     41     115  
Age  
[units: years]
Mean ± Standard Deviation
  53.7  ± 16.6     56.3  ± 16.9     55.6  ± 17.2     55.2  ± 16.9  
Gender  
[units: participants]
       
Female     93     86     90     269  
Male     10     16     13     39  
Region of Enrollment  
[units: participants]
       
Japan     103     102     103     308  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline, 4weeks ]

2.  Secondary:   Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline, 4weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Eiji Murakami
Organization: Dermatologicals & Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.
phone: +81-6-6231-6067


No publications provided by Otsuka Pharmaceutical Co., Ltd.

Publications automatically indexed to this study:

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00475319     History of Changes
Other Study ID Numbers: 037E-06-001
Study First Received: May 16, 2007
Results First Received: January 31, 2013
Last Updated: June 4, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare