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DE-111 Against Timolol Ophthalmic Solution 0.5%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342094
First received: April 24, 2011
Last updated: June 14, 2015
Last verified: June 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: Timolol ophthalmic solution 0.5%
Drug: Placebo ophthalmic solution

  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
Prior to randomization all participants in the study were receiving Timolol ophthalmic solution 0.5% (one drop at a time, BID).

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.
Timolol Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.

Participant Flow:   Overall Study
    DE-111   Timolol
STARTED   82   84 
COMPLETED   77   81 
NOT COMPLETED   5   3 
Adverse Event                5                0 
Not meeting inclusion/exclusion criteria                0                1 
Withdrawal by Subject                0                2 



  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.

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.
Timolol Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
Total Total of all reporting groups

Baseline Measures
   DE-111   Timolol   Total 
Overall Participants Analyzed 
[Units: Participants]
 82   84   166 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   46   35   81 
>=65 years   36   49   85 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (11.4)   63.1  (12.4)   62.4  (11.9) 
Gender 
[Units: Participants]
     
Female   44   46   90 
Male   38   38   76 
Region of Enrollment 
[Units: Participants]
     
Japan   82   84   166 


  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: NCT01342094     History of Changes
Other Study ID Numbers: 01111005
Study First Received: April 24, 2011
Results First Received: April 28, 2015
Last Updated: June 14, 2015