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DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342081
First received: April 25, 2011
Last updated: May 19, 2015
Last verified: May 2015
Results First Received: April 28, 2015  
Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Open Angle Glaucoma
Ocular Hypertension
Interventions: Drug: DE-111 ophthalmic solution
Drug: Tafluprost ophthalmic solution 0.0015%
Drug: Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Switched to following three arms randomly from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily).

Reporting Groups
  Description
DE-111 DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Tafluprost Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Tafluprost Plus Timolol Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.

Participant Flow:   Overall Study
    DE-111     Tafluprost     Tafluprost Plus Timolol  
STARTED     161     164     164  
COMPLETED     159     162     163  
NOT COMPLETED     2     2     1  
Did not receive allocated intervention                 0                 0                 1  
Adverse Event                 1                 0                 0  
Physician Decision                 0                 1                 0  
Withdrawal by Subject                 1                 1                 0  



  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.

Subjects who have instilled the investigational drug at least once. Excluded from analysis in Tafluprost (n=1).

Reason: Protocol Violation


Reporting Groups
  Description
DE-111 DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Tafluprost Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Tafluprost Plus Timolol Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
Total Total of all reporting groups

Baseline Measures
    DE-111     Tafluprost     Tafluprost Plus Timolol     Total  
Number of Participants  
[units: participants]
  161     163     163     487  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     92     81     87     260  
>=65 years     69     82     76     227  
Age  
[units: years]
Mean (Standard Deviation)
  61.6  (11.6)     63.0  (12.6)     60.6  (13.6)     61.7  (12.7)  
Gender  
[units: participants]
       
Female     76     95     81     252  
Male     85     68     82     235  
Region of Enrollment  
[units: participants]
       
Japan     161     163     163     487  



  Outcome Measures

1.  Primary:   Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study   [ Time Frame: Week 0(Baseline) and Week 4(End of Study) ]


  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: General Manager of Clinical Development Group
Organization: Santen Pharmaceutical Co., Ltd.
phone: +81-6-4802-9341
e-mail: clinical@santen.co.jp



Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01342081     History of Changes
Other Study ID Numbers: 01111004
Study First Received: April 25, 2011
Results First Received: April 28, 2015
Last Updated: May 19, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare