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  
Number of Participants  
[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


No publications provided


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
Health Authority: Japan: Ministry of Health, Labor and Welfare