Trial Outcomes & Findings for Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data (NCT NCT01145898)

NCT ID: NCT01145898

Last Updated: 2014-01-22

Results Overview

Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

• Recruitment status: COMPLETED
• Target enrollment: 56 participants
• Primary outcome timeframe: Baseline and 6 month visits
• Results posted on: 2014-01-22

Participant Flow

recruitment over 6 months. Hospital and area eye clinics

observational study, patients were treated by their physician not by study personel, treatments/interventions were self-reported by the patients, treatment was not necessarily started at glaucoma diagnosis

Participant milestones

Measure	Trusopt Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months	Prostaglandin Alone Patients with glaucoma taking prostaglandin alone for at least 6 months
6-month Treatment STARTED	12	44
6-month Treatment COMPLETED	12	44
6-month Treatment NOT COMPLETED	0	0
3-year Treatment STARTED	12	44
3-year Treatment COMPLETED	9	28
3-year Treatment NOT COMPLETED	3	16

Reasons for withdrawal

Measure	Trusopt Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months	Prostaglandin Alone Patients with glaucoma taking prostaglandin alone for at least 6 months
3-year Treatment medication change by treating physician	3	16

Baseline Characteristics

Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data

Baseline characteristics by cohort

Measure	Trusopt n=12 Participants Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months	Prostaglandin Alone n=44 Participants Patients with glaucoma taking prostaglandin alone for at least 6 months	Total n=56 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	7 Participants n=5 Participants	17 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	27 Participants n=7 Participants	32 Participants n=5 Participants
Age, Continuous	63.23 years STANDARD_DEVIATION 6.78 • n=5 Participants	65.25 years STANDARD_DEVIATION 8.78 • n=7 Participants	64.82 years STANDARD_DEVIATION 8.38 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	31 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	44 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

Outcome measures

Measure	Trusopt n=12 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=44 Participants Patients taking prostaglandin alone
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)	2.32 cm/sec Standard Error 1.20	-.30 cm/sec Standard Error 1.17

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity

Outcome measures

Measure	Trusopt n=12 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=44 Participants Patients taking prostaglandin alone
6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)	.78 cm/sec Standard Error .63	-.03 cm/sec Standard Error .39

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.

Outcome measures

Measure	Trusopt n=12 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=44 Participants Patients taking prostaglandin alone
6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)	-.011 unitless Standard Error .020	.002 unitless Standard Error .008

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity

Outcome measures

Measure	Trusopt n=12 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=44 Participants Patients taking prostaglandin alone
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)	0.24 cm/sec Standard Error .34	-.045 cm/sec Standard Error .15

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity

Outcome measures

Measure	Trusopt n=12 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=44 Participants Patients taking prostaglandin alone
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)	.18 cm/sec Standard Error .16	-.12 cm/sec Standard Error .07

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.

Outcome measures

Measure	Trusopt n=12 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=44 Participants Patients taking prostaglandin alone
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)	-.012 unitless Standard Error .012	.005 unitless Standard Error .008

PRIMARY outcome

Timeframe: Baseline and 6 month visits

Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.

Outcome measures

Measure	Trusopt n=12 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=44 Participants Patients taking prostaglandin alone
6-month Change in Ocular Perfusion Pressures (OPP)	-.30 mm Hg Standard Error 2.02	-2.88 mm Hg Standard Error 1.06

PRIMARY outcome

Timeframe: Baseline and 36 month visits

Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

Outcome measures

Measure	Trusopt n=9 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=27 Participants Patients taking prostaglandin alone
3-year Change in OA PSV	-.62 cm/sec Standard Error 2.41	.07 cm/sec Standard Error 1.25

PRIMARY outcome

Timeframe: Baseline and 36 month visits

Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity

Outcome measures

Measure	Trusopt n=9 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=27 Participants Patients taking prostaglandin alone
3-year Change in OA EDV	-.58 cm/sec Standard Error .58	-.98 cm/sec Standard Error .35

PRIMARY outcome

Timeframe: Baseline and 36 month visits

Measurement of change in ocular blood flow - ophthalmic artery resistance index

Outcome measures

Measure	Trusopt n=9 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=27 Participants Patients taking prostaglandin alone
3-year Change in OA RI	.042 unitless Standard Error .026	.036 unitless Standard Error .013

PRIMARY outcome

Timeframe: Baseline and 36 month visits

Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity

Outcome measures

Measure	Trusopt n=9 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=27 Participants Patients taking prostaglandin alone
3-year Change in CRA PSV	-.66 cm/sec Standard Error .61	.37 cm/sec Standard Error .40

PRIMARY outcome

Timeframe: Baseline and 36 month visits

Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity

Outcome measures

Measure	Trusopt n=9 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=27 Participants Patients taking prostaglandin alone
3-year Change in CRA EDV	-.21 cm/sec Standard Error .21	.12 cm/sec Standard Error .13

PRIMARY outcome

Timeframe: Baseline and 36 month visits

Measurement of change in ocular blood flow - central retinal arteries resistance index

Outcome measures

Measure	Trusopt n=9 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=27 Participants Patients taking prostaglandin alone
3-year Change in CRA RI	.007 unitless Standard Error .024	.013 unitless Standard Error .014

PRIMARY outcome

Timeframe: Baseline and 36 month visits

Measurement of change in ocular perfusion pressure

Outcome measures

Measure	Trusopt n=9 Participants Patients taking trusopt or cosopt alone or with prostaglandin	Prostaglandin Alone n=27 Participants Patients taking prostaglandin alone
3-year Change in OPP	-4.91 mm Hg Standard Error 2.74	-1.43 mm Hg Standard Error 1.50

Adverse Events

Glaucoma Patients

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: 317-278-00177

Email: alharris@indiana.edu

Results disclosure agreements

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