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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01145898
First Posted: June 17, 2010
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University
  Purpose
To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

Condition Intervention
Glaucoma Drug: (Cosopt®, prostaglandin)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) [ Time Frame: Baseline and 6 month visits ]
    Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

  • 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV) [ Time Frame: Baseline and 6 month visits ]
    Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity

  • 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI) [ Time Frame: 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.

  • 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) [ Time Frame: Baseline and 6 month visits ]
    Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity

  • 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) [ Time Frame: Baseline and 6 month visits ]
    Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity

  • 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) [ Time Frame: 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.

  • 6-month Change in Ocular Perfusion Pressures (OPP) [ Time Frame: 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.

  • 3-year Change in OA PSV [ Time Frame: Baseline and 36 month visits ]
    Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

  • 3-year Change in OA EDV [ Time Frame: Baseline and 36 month visits ]
    Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity

  • 3-year Change in OA RI [ Time Frame: Baseline and 36 month visits ]
    Measurement of change in ocular blood flow - ophthalmic artery resistance index

  • 3-year Change in CRA PSV [ Time Frame: Baseline and 36 month visits ]
    Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity

  • 3-year Change in CRA EDV [ Time Frame: Baseline and 36 month visits ]
    Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity

  • 3-year Change in CRA RI [ Time Frame: Baseline and 36 month visits ]
    Measurement of change in ocular blood flow - central retinal arteries resistance index

  • 3-year Change in OPP [ Time Frame: Baseline and 36 month visits ]
    Measurement of change in ocular perfusion pressure


Enrollment: 56
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Glaucoma patients
Patients with Glaucoma
Drug: (Cosopt®, prostaglandin)
We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.
Other Name: Cosopt is a trade name drug which is a combination of dorzolamide and timolol.

Detailed Description:
To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Glaucoma patients
Criteria

Inclusion Criteria:

  1. Age: 30 years or older.
  2. Diagnosis: confirmed open-angle glaucoma in at least one eye:

    1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
    2. glaucomatous optic disc cupping
    3. agreement between two baseline exams for reliability
  3. Best corrected visual acuity at least 20/60 in at least one eye.
  4. Prior Humphrey visual fields demonstrate acceptable reliability standards.

Exclusion Criteria:

  1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
  2. Evidence of exfoliation or pigment dispersion.
  3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
  4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
  5. History or signs of intraocular trauma.
  6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
  7. Any abnormality preventing reliable applanation tonometry.
  8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
  9. Cataract surgery within the past year.
  10. Resting pulse < 50 beats per minute.
  11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145898


Locations
United States, Indiana
Indiana University School of Medicine, Department of Ophthalmology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Alon Harris, PhD Indiana University School of Medicine
  More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01145898     History of Changes
Other Study ID Numbers: Cosopt and OAG progression
First Submitted: June 15, 2010
First Posted: June 17, 2010
Results First Submitted: September 20, 2013
Results First Posted: January 22, 2014
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Indiana University:
Glaucoma
Cosopt
blood flow
progression

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Dorzolamide
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action