DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01343082
First received: April 24, 2011
Last updated: May 19, 2015
Last verified: May 2015
Results First Received: April 28, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Open Angle Glaucoma or Ocular Hypertension
Intervention: Drug: DE-111 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
The run-in period of 4 weeks. Switched to DE-111 ophthalmic solution from Tafluprost ophthalmic solution 0.0015%, Timolol ophthalmic solution 0.5%, or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% . Treatment period: 52 weeks .

Reporting Groups
  Description
Allocated to Tafluprost Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
Allocated to Timolol Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
Allocated to Tafluprost + Timolol Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.

Participant Flow for 2 periods

Period 1:   The run-in Period
    Allocated to Tafluprost     Allocated to Timolol     Allocated to Tafluprost + Timolol  
STARTED     51     49     48  
COMPLETED     48     45     43  
NOT COMPLETED     3     4     5  
Not meeting criteria                 3                 4                 5  

Period 2:   Treatment Period , Switched to DE-111
    Allocated to Tafluprost     Allocated to Timolol     Allocated to Tafluprost + Timolol  
STARTED     48     45     43  
COMPLETED     43     36     31  
NOT COMPLETED     5     9     12  
Adverse Event                 1                 4                 3  
Lack of Efficacy                 0                 1                 2  
Physician Decision                 0                 2                 2  
Withdrawal by Subject                 4                 2                 5  



  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
DE-111 Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .

Baseline Measures
    DE-111  
Number of Participants  
[units: participants]
  136  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     62  
>=65 years     74  
Age  
[units: years]
Mean (Standard Deviation)
  64.0  (12.0)  
Gender  
[units: participants]
 
Female     81  
Male     55  
Region of Enrollment  
[units: participants]
 
Japan     136  



  Outcome Measures

1.  Primary:   Change From Baseline in IOP (Intraocular Pressure) at End of Study   [ Time Frame: Treatment period: Week 0 (Baseline) and Week 52 (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: NCT01343082     History of Changes
Other Study ID Numbers: 01111006
Study First Received: April 24, 2011
Results First Received: April 28, 2015
Last Updated: May 19, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare