Trial Outcomes & Findings for Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow (NCT NCT00811850)

NCT ID: NCT00811850

Last Updated: 2019-04-24

Results Overview

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 1 Month
• Results posted on: 2019-04-24

Participant Flow

Participant milestones

Measure	All Patients This was a cross-over study with 3 treatment periods. In Treatment Period 1, patients received either Combigan® or Cosopt®. In Treatment Period 2, patients were washed out of their previous treatment. In Treatment Period 3, patients received either Combigan® or Cosopt® (treatment not received in Treatment Period 1).
Treatment Period 1: Combigan® or Cosopt® STARTED	15
Treatment Period 1: Combigan® or Cosopt® COMPLETED	15
Treatment Period 1: Combigan® or Cosopt® NOT COMPLETED	0
Treatment Period 2: Wash Out STARTED	15
Treatment Period 2: Wash Out COMPLETED	15
Treatment Period 2: Wash Out NOT COMPLETED	0
Treatment Period 3: Combigan® or Cosopt® STARTED	15
Treatment Period 3: Combigan® or Cosopt® COMPLETED	15
Treatment Period 3: Combigan® or Cosopt® NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow

Baseline characteristics by cohort

Measure	All Patients n=15 Participants All patients in the study
Age, Continuous	68.1 years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery	8.61 Centimeters per second (cm/s) Standard Deviation 2.33	8.02 Centimeters per second (cm/s) Standard Deviation 2.51

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery	2.63 Centimeters per second (cm/s) Standard Deviation 0.71	2.61 Centimeters per second (cm/s) Standard Deviation 0.63

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery	8.52 Centimeters per second (cm/s) Standard Deviation 1.57	8.84 Centimeters per second (cm/s) Standard Deviation 1.75

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery	2.73 Centimeters per second (cm/s) Standard Deviation 0.67	2.87 Centimeters per second (cm/s) Standard Deviation 0.95

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery	24.5 Centimeters per second (cm/s) Standard Deviation 11.25	22.09 Centimeters per second (cm/s) Standard Deviation 8.25

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery	5.83 Centimeters per second (cm/s) Standard Deviation 2.49	5.18 Centimeters per second (cm/s) Standard Deviation 2.33

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery	8.86 Centimeters per second (cm/s) Standard Deviation 2.19	8.81 Centimeters per second (cm/s) Standard Deviation 2.54

PRIMARY outcome

Timeframe: 1 Month

Population: Intent-to-treat population, which consisted of all patients that started the study (randomized)

End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).

Outcome measures

Measure	Combigan® n=15 Participants Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.	Cosopt® n=15 Participants Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery	2.73 Centimeters per second (cm/s) Standard Deviation 0.65	2.75 Centimeters per second (cm/s) Standard Deviation 0.78

Adverse Events

Combigan®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cosopt®

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: clinicaltrials@allergan.com

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 30 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