Trial Outcomes & Findings for Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow (NCT NCT01308788)

NCT ID: NCT01308788

Last Updated: 2014-01-27

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 35 participants
• Primary outcome timeframe: Baseline and 6 month visits
• Results posted on: 2014-01-27

Participant Flow

recited over 6 months

Participant milestones

Measure	Aqueous Outflow aqueous outflow treated	Aqueous Suppressant aqueous suppressant treated
6-month Treatment STARTED	14	21
6-month Treatment COMPLETED	14	21
6-month Treatment NOT COMPLETED	0	0
2-year Treatment STARTED	14	21
2-year Treatment COMPLETED	10	10
2-year Treatment NOT COMPLETED	4	11

Reasons for withdrawal

Measure	Aqueous Outflow aqueous outflow treated	Aqueous Suppressant aqueous suppressant treated
2-year Treatment medication change by treating physician	4	11

Baseline Characteristics

Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

Baseline characteristics by cohort

Measure	Aqueous Suppressant n=21 Participants aqueous suppressant treated	Aqueous Outflow n=14 Participants aqueous outflow treated	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	14 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Outcome measures

Measure	Aqueous Outflow n=14 Participants aqueous outflow treated	Aqueous Suppressant n=21 Participants aqueous suppressant treated
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)	-.70 cm/sec Standard Error 2.57	1.84 cm/sec Standard Error .96

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Outcome measures

Measure	Aqueous Outflow n=14 Participants aqueous outflow treated	Aqueous Suppressant n=21 Participants aqueous suppressant treated
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)	-.36 cm/sec Standard Error .78	.12 cm/sec Standard Error .44

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Outcome measures

Measure	Aqueous Outflow n=14 Participants aqueous outflow treated	Aqueous Suppressant n=21 Participants aqueous suppressant treated
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)	.003 unitless Standard Error .011	.014 unitless Standard Error .013

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Outcome measures

Measure	Aqueous Outflow n=14 Participants aqueous outflow treated	Aqueous Suppressant n=21 Participants aqueous suppressant treated
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)	-.16 cm/sec Standard Error .28	.09 cm/sec Standard Error .25

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Outcome measures

Measure	Aqueous Outflow n=14 Participants aqueous outflow treated	Aqueous Suppressant n=21 Participants aqueous suppressant treated
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)	-.13 cm/sec Standard Error .10	-.03 cm/sec Standard Error .11

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Outcome measures

Measure	Aqueous Outflow n=14 Participants aqueous outflow treated	Aqueous Suppressant n=21 Participants aqueous suppressant treated
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)	.029 unitless Standard Error .018	.005 unitless Standard Error .010

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Outcome measures

Measure	Aqueous Outflow n=14 Participants aqueous outflow treated	Aqueous Suppressant n=21 Participants aqueous suppressant treated
6-month Change in Ocular Perfusion Pressures (OPP)	-3.38 mm Hg Standard Error 2.26	-.63 mm Hg Standard Error 2.36

PRIMARY outcome

Timeframe: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

Outcome measures

Measure	Aqueous Outflow n=10 Participants aqueous outflow treated	Aqueous Suppressant n=9 Participants aqueous suppressant treated
2-year Change in OA PSV	1.39 cm/sec Standard Error 3.05	2.63 cm/sec Standard Error 3.40

PRIMARY outcome

Timeframe: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

Outcome measures

Measure	Aqueous Outflow n=10 Participants aqueous outflow treated	Aqueous Suppressant n=9 Participants aqueous suppressant treated
2-year Change in OA EDV	-1.28 cm/sec Standard Error .71	.34 cm/sec Standard Error .62

PRIMARY outcome

Timeframe: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

Outcome measures

Measure	Aqueous Outflow n=10 Participants aqueous outflow treated	Aqueous Suppressant n=9 Participants aqueous suppressant treated
2-year Change in OA RI	.035 unitless Standard Error .016	.019 unitless Standard Error .029

PRIMARY outcome

Timeframe: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

Outcome measures

Measure	Aqueous Outflow n=10 Participants aqueous outflow treated	Aqueous Suppressant n=9 Participants aqueous suppressant treated
2-year Change in CRA PSV	1.46 cm/sec Standard Error .64	.19 cm/sec Standard Error .50

PRIMARY outcome

Timeframe: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

Outcome measures

Measure	Aqueous Outflow n=10 Participants aqueous outflow treated	Aqueous Suppressant n=9 Participants aqueous suppressant treated
2-year Change in CRA EDV	.43 cm/sec Standard Error .24	.16 cm/sec Standard Error .33

PRIMARY outcome

Timeframe: Baseline and 24 month visits

Population: one participant was unable to be measured for this outcome

Outcome measures

Measure	Aqueous Outflow n=10 Participants aqueous outflow treated	Aqueous Suppressant n=9 Participants aqueous suppressant treated
2-year Change in CRA RI	.005 unitless Standard Error .017	-.010 unitless Standard Error .030

PRIMARY outcome

Timeframe: Baseline and 24 month visits

Outcome measures

Measure	Aqueous Outflow n=10 Participants aqueous outflow treated	Aqueous Suppressant n=10 Participants aqueous suppressant treated
2-year Change in OPP	-1.26 mm Hg Standard Error 3.36	-3.02 mm Hg Standard Error 4.69

Adverse Events

Aqueous Outflow

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aqueous Suppressant

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

Alon Harris

Indiana University

Phone: 3170278-0177

Email: alharris@indiana.edu

Results disclosure agreements

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