Trial Outcomes & Findings for 24-hour IOP-lowering Effect of Brimonidine 0.1% (NCT NCT00457795)

Results Overview

IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Week 4

Results posted on

2011-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	Brimonidine 0.1% Brimonidine 0.1%
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

24-hour IOP-lowering Effect of Brimonidine 0.1%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brimonidine 0.1% n=15 Participants Brimonidine 0.1%
Age Continuous	58.3 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Intent to Treat defined as all patients who started the study (randomized)

IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.

Outcome measures

Outcome measures
Measure	Brimonidine 0.1% n=15 Participants Brimonidine 0.1%
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Diurnal IOP Sitting at Week 4	16.8 Millimeters of mercury (mmHg) Standard Deviation 2.8
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Diurnal IOP Supine at Week 4	21.1 Millimeters of mercury (mmHg) Standard Deviation 2.3
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Nocturnal IOP Supine at Week 4	23.0 Millimeters of mercury (mmHg) Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intent to Treat defined as all patients who started the study (randomized)

Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Brimonidine 0.1% n=15 Participants Brimonidine 0.1%
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Diurnal IOP Sitting at Baseline	19.2 Millimeters of mercury (mmHg) Standard Deviation 2.7
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Diurnal IOP Supine at Baseline	23.1 Millimeters of mercury (mmHg) Standard Deviation 2.1
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Nocturnal IOP Supine at Baseline	22.7 Millimeters of mercury (mmHg) Standard Deviation 2.6
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Diurnal IOP Sitting Change from Baseline at Week 4	-2.4 Millimeters of mercury (mmHg) Standard Deviation 1.4
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Diurnal IOP Supine Change from Baseline at Week 4	-1.9 Millimeters of mercury (mmHg) Standard Deviation 1.3
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4 Nocturnal IOP Supine Change from Baseline at Wk 4	0.3 Millimeters of mercury (mmHg) Standard Deviation 1.9

SECONDARY outcome

Timeframe: Week 4

Population: Intent to Treat defined as all patients who started the study (randomized)

Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.

Outcome measures

Outcome measures
Measure	Brimonidine 0.1% n=15 Participants Brimonidine 0.1%
Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 Diurnal OPP Sitting at Week 4	46.8 Millimeters of mercury (mmHg) Standard Deviation 7.6
Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 Diurnal OPP Supine at Week 4	53.8 Millimeters of mercury (mmHg) Standard Deviation 9.8
Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4 Nocturnal OPP Supine at Week 4	49.2 Millimeters of mercury (mmHg) Standard Deviation 11.2

SECONDARY outcome

Timeframe: Week 4

Population: Intent to Treat defined as all patients who started the study (randomized)

Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.

Outcome measures

Outcome measures
Measure	Brimonidine 0.1% n=15 Participants Brimonidine 0.1%
Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 Diurnal Change in OPP Sitting at Week 4	1.1 Millimeters of mercury (mmHg) Standard Deviation 5.6
Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 Diurnal Change in OPP Supine at Week 4	0.3 Millimeters of mercury (mmHg) Standard Deviation 4.9
Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4 Nocturnal Change in OPP Supine at Week 4	-3.0 Millimeters of mercury (mmHg) Standard Deviation 6.1

Adverse Events

Brimonidine 0.1%

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

Vice President, Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Publication restrictions are in place

Restriction type: OTHER