Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01145898
First received: June 15, 2010
Last updated: January 17, 2014
Last verified: January 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measurement of change in ocular blood flow - ophthalmic artery resistance index

  • 3-year Change in CRA PSV [ Time Frame: Baseline and 36 month visits ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measurement of change in ocular blood flow - central retinal arteries resistance index

  • 3-year Change in OPP [ Time Frame: Baseline and 36 month visits ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01145898     History of Changes
Other Study ID Numbers: Cosopt and OAG progression
Study First Received: June 15, 2010
Results First Received: September 20, 2013
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Glaucoma
Cosopt
blood flow
progression

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 25, 2014