24-hour IOP-lowering Effect of 0.01% Bimatoprost

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Liu, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01271686
First received: January 6, 2011
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: December 17, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Intraocular Pressure
Glaucoma
Ocular Hypertension
Intervention: Drug: 0.01% bimatoprost

  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
Experimental subjects were recruited consecutively from patients with diagnosed bilateral primary open angle glaucoma or ocular hypertension at the Hamilton Glaucoma Center of the University of California, San Diego.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who smoked, had previous glaucoma surgery in either eye, had a history of ocular trauma or a sleep disorder, or had an irregular sleep schedule were excluded.

Reporting Groups
  Description
0.01% Bimatoprost 0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks

Participant Flow:   Overall Study
    0.01% Bimatoprost  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     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.
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Reporting Groups
  Description
0.01% Bimatoprost 0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks

Baseline Measures
    0.01% Bimatoprost  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 8.5  
Gender  
[units: participants]
 
Female     6  
Male     10  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     12  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     15  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures

1.  Primary:   Nocturnal Intraocular Pressure (IOP) Change   [ Time Frame: 4 weeks ]


  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: Dr. John Liu
Organization: University of California, San Diego
phone: 858 534-7056
e-mail: joliu@ucsd.edu


Publications of Results:

Responsible Party: John Liu, PhD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01271686     History of Changes
Other Study ID Numbers: UCSD 101705 bimatoprost
Study First Received: January 6, 2011
Results First Received: December 17, 2013
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration