24-hour IOP-lowering Effect of 0.01% Bimatoprost

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01271686
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : June 19, 2014
Last Update Posted : June 19, 2014
Information provided by (Responsible Party):
John Liu, PhD, University of California, San Diego

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Intraocular Pressure
Ocular Hypertension
Intervention: Drug: 0.01% bimatoprost

  Participant Flow

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
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

  Baseline Characteristics

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
0.01% Bimatoprost 0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks

Baseline Measures
   0.01% Bimatoprost 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 61  (8.5) 
[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

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
No text entered.

  More Information

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

Publications of Results:

Responsible Party: John Liu, PhD, University of California, San Diego Identifier: NCT01271686     History of Changes
Other Study ID Numbers: UCSD 101705 bimatoprost
First Submitted: January 6, 2011
First Posted: January 7, 2011
Results First Submitted: December 17, 2013
Results First Posted: June 19, 2014
Last Update Posted: June 19, 2014