Trial Outcomes & Findings for Aqueous Humor Dynamics and Brimonidine (NCT NCT01144494)

Results Overview

Seated day-time and supine day-time IOP was measured by pneumatonometer at 9 am and 11 am. Seated night-time IOP was measured at 9 pm and 11 pm.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

35 participants

Primary outcome timeframe

6 weeks

Results posted on

2023-11-28

Participant Flow

2 subjects consented and then dropped out prior to assignment.

Participant milestones

Participant milestones
Measure	IOP Lowering Drug Then Art Tears Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks. Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears Then IOP Lowering Drug Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.
Overall Study STARTED	15	18
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aqueous Humor Dynamics and Brimonidine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=29 Participants participants were randomized to receive both IOP lowering drug and lubricating drops in a randomized order
Age, Continuous	58.6 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants
Race/Ethnicity, Customized African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: some patients were consented but did not participate due to various reasons

Seated day-time and supine day-time IOP was measured by pneumatonometer at 9 am and 11 am. Seated night-time IOP was measured at 9 pm and 11 pm.

Outcome measures

Outcome measures
Measure	Intraocular Pressure Lowering Drug n=29 Participants Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.	Artificial Tears n=29 Participants Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Day) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Night) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks
Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm Seated day-time 9 am	18.1 mmHg Standard Error 0.7	20.3 mmHg Standard Error 0.7	—	—
Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm Seated day-time 11 am	18.0 mmHg Standard Error 0.7	19.9 mmHg Standard Error 0.8	—	—
Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm Supine day-time 9 am	23.1 mmHg Standard Error 0.7	25.4 mmHg Standard Error 0.7	—	—
Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm Supine day-time 11 am	23.1 mmHg Standard Error 0.7	24.7 mmHg Standard Error 0.8	—	—
Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm Seated night-time 9 pm	16.0 mmHg Standard Error 0.6	18.0 mmHg Standard Error 0.7	—	—
Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm Seated night-time 11 pm	16.7 mmHg Standard Error 0.7	18.4 mmHg Standard Error 0.7	—	—

PRIMARY outcome

Timeframe: 6 weeks plus 2 days

Population: some patients were consented but did not participate due to various reasons

The episcleral venous pressure was measured using the episcleral venomanometer

Outcome measures

Outcome measures
Measure	Intraocular Pressure Lowering Drug n=27 Participants Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.	Artificial Tears n=27 Participants Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Day) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Night) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks
Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP) Daytime Seated	10.3 mmHg Standard Error 0.2	10.3 mmHg Standard Error 0.2	—	—
Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP) Nighttime Supine	11.3 mmHg Standard Error 0.3	11.2 mmHg Standard Error 0.2	—	—

SECONDARY outcome

Timeframe: 6 weeks

Population: Measurements were taken in the day and night for each group and analysis was done comparing the difference between and within both groups in the day and night respectively. some patients were consented but did not participate due to various reasons

Measured by fluorophotometry during the day and night on 29 participants.

Outcome measures

Outcome measures
Measure	Intraocular Pressure Lowering Drug n=29 Participants Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.	Artificial Tears n=29 Participants Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Day) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Night) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks
Aqueous Flow day-time measurement	2.4 µl/min Standard Error 0.1	2.3 µl/min Standard Error 0.1	—	—
Aqueous Flow night-time measurement	1.5 µl/min Standard Error 0.1	1.5 µl/min Standard Error 0.1	—	—

SECONDARY outcome

Timeframe: 6 weeks

Population: Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants. some patients were consented but did not participate due to various reasons

Calculated from the modified Goldmann equation using data obtained at 9 am and 11 am. Goldmann equation involves data from aqueous flow, tonography/outflow facility, episcleral venous pressure and IOP. Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants.

Outcome measures

Outcome measures
Measure	Intraocular Pressure Lowering Drug n=27 Participants Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.	Artificial Tears n=27 Participants Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Day) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Night) Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks
Uveoscleral Outflow	0.84 μL/min Interval 0.24 to 1.46	0.72 μL/min Interval 0.11 to 1.34	—	—

SECONDARY outcome

Timeframe: 6 weeks

Population: Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants. some patients were consented but did not participate due to various reasons

Calculated from the measurement taken during the day and night. Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants.

Outcome measures

Outcome measures
Measure	Intraocular Pressure Lowering Drug n=27 Participants Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.	Artificial Tears n=27 Participants Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Day) n=27 Participants Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks	Artificial Tears (Night) n=27 Participants Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks
Outflow Facility	0.28 μL/min Standard Error 0.02	0.28 μL/min Standard Error 0.02	0.29 μL/min Standard Error 0.02	0.29 μL/min Standard Error 0.02

Adverse Events

Intraocular Pressure Lowering Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Artificial Tears

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intraocular Pressure Lowering Drug n=33 participants at risk Eyedrops for lowering intraocular pressure Brimonidine: One drop of brimonidine in each eye three times a day for six weeks.	Artificial Tears n=33 participants at risk Lubricated eye drops Artificial tears: Lubricating drops added three times a day for six weeks
Eye disorders IOP equal to 35mmHg	0.00% 0/33	3.0% 1/33
Eye disorders Acute anterior uveitis	0.00% 0/33	9.1% 3/33
Eye disorders Corneal Epitheliopathy	0.00% 0/33	3.0% 1/33

Additional Information

Carol Toris

University of Nebraska Medical Center

Phone: 402-559-1852

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place