Trial Outcomes & Findings for 24-hour IOP-lowering Effect of 0.01% Bimatoprost (NCT NCT01271686)

NCT ID: NCT01271686

Last Updated: 2014-06-19

Results Overview

Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2014-06-19

Participant Flow

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.

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.

Participant milestones

Measure	0.01% Bimatoprost 0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

24-hour IOP-lowering Effect of 0.01% Bimatoprost

Baseline characteristics by cohort

Measure	0.01% Bimatoprost n=16 Participants 0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks
Age, Continuous	61 years STANDARD_DEVIATION 8.5 • n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	16 participants n=93 Participants

PRIMARY outcome

Timeframe: 4 weeks

Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.

Outcome measures

Measure	0.01% Bimatoprost n=16 Participants 0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
Nocturnal Intraocular Pressure (IOP) Change	-2.6 mmHg Standard Deviation 2.8

Adverse Events

0.01% Bimatoprost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Liu

University of California, San Diego

Phone: 858 534-7056

Email: joliu@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place