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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT00811850
Collaborator
(none)
15
1
2
12
1.3

Study Details

Study Description

Brief Summary

A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.

Condition or Disease Intervention/Treatment Phase
  • Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
  • Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Combigan®

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.

Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks
Other Names:
  • Combigan®
  • Active Comparator: Cosopt®

    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.

    Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution
    1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks
    Other Names:
  • Cosopt®
  • Outcome Measures

    Primary Outcome Measures

    1. Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery [1 Month]

      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).

    2. Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery [1 Month]

      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).

    3. Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery [1 Month]

      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).

    4. Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery [1 Month]

      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).

    5. Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery [1 Month]

      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).

    6. Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery [1 Month]

      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).

    7. Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery [1 Month]

      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).

    8. Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery [1 Month]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age: 30 years or older.

    2. Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.

    3. Best corrected visual acuity at least 20/40 in at least one eye.

    Exclusion Criteria:
    1. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.

    2. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).

    3. History or signs of intraocular trauma.

    4. Any abnormality preventing reliable applanation tonometry.

    5. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.

    6. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indianapolis Indiana United States

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT00811850
    Other Study ID Numbers:
    • GMA-COM-08-009
    First Posted:
    Dec 19, 2008
    Last Update Posted:
    Apr 24, 2019
    Last Verified:
    Apr 1, 2019

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title All Patients
    Arm/Group Description 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).
    Period Title: Treatment Period 1: Combigan® or Cosopt®
    STARTED 15
    COMPLETED 15
    NOT COMPLETED 0
    Period Title: Treatment Period 1: Combigan® or Cosopt®
    STARTED 15
    COMPLETED 15
    NOT COMPLETED 0
    Period Title: Treatment Period 1: Combigan® or Cosopt®
    STARTED 15
    COMPLETED 15
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title All Patients
    Arm/Group Description All patients in the study
    Overall Participants 15
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    68.1
    (NA)
    Sex: Female, Male (Count of Participants)
    Female
    8
    53.3%
    Male
    7
    46.7%

    Outcome Measures

    1. Primary Outcome
    Title Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    8.61
    (2.33)
    8.02
    (2.51)
    2. Primary Outcome
    Title Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    2.63
    (0.71)
    2.61
    (0.63)
    3. Primary Outcome
    Title Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    8.52
    (1.57)
    8.84
    (1.75)
    4. Primary Outcome
    Title Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    2.73
    (0.67)
    2.87
    (0.95)
    5. Primary Outcome
    Title Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    24.5
    (11.25)
    22.09
    (8.25)
    6. Primary Outcome
    Title Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    5.83
    (2.49)
    5.18
    (2.33)
    7. Primary Outcome
    Title Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    8.86
    (2.19)
    8.81
    (2.54)
    8. Primary Outcome
    Title Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery
    Description 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).
    Time Frame 1 Month

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population, which consisted of all patients that started the study (randomized)
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    Measure Participants 15 15
    Mean (Standard Deviation) [Centimeters per second (cm/s)]
    2.73
    (0.65)
    2.75
    (0.78)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Combigan® Cosopt®
    Arm/Group Description 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® (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.
    All Cause Mortality
    Combigan® Cosopt®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Combigan® Cosopt®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Combigan® Cosopt®
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Results Point of Contact

    Name/Title Vice President, Medical Affairs
    Organization Allergan, Inc.
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT00811850
    Other Study ID Numbers:
    • GMA-COM-08-009
    First Posted:
    Dec 19, 2008
    Last Update Posted:
    Apr 24, 2019
    Last Verified:
    Apr 1, 2019