NCT01308788

Brief Summary

The purpose of this study will be to compare the aqueous production suppressant to aqueous outflow drugs in terms of the response to known vascular parameters. Specifically; systemic perfusion pressure, retrobulbar blood flow and retinal microcirculation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 27, 2014

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

March 2, 2011

Results QC Date

September 20, 2013

Last Update Submit

January 23, 2014

Conditions

Glaucoma

Keywords

glaucoma blood flow

Outcome Measures

Primary Outcomes (14)

  • 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)

    Baseline and 6 month visits

  • 6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)

    Baseline and 6 month visits

  • 6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)

    Baseline and 6 month visits

  • 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)

    Baseline and 6 month visits

  • 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)

    Baseline and 6 month visits

  • 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)

    Baseline and 6 month visits

  • 6-month Change in Ocular Perfusion Pressures (OPP)

    Baseline and 6 month visits

  • 2-year Change in OA PSV

    Baseline and 24 month visits

  • 2-year Change in OA EDV

    Baseline and 24 month visits

  • 2-year Change in OA RI

    Baseline and 24 month visits

  • 2-year Change in CRA PSV

    Baseline and 24 month visits

  • 2-year Change in CRA EDV

    Baseline and 24 month visits

  • 2-year Change in CRA RI

    Baseline and 24 month visits

  • 2-year Change in OPP

    Baseline and 24 month visits

Study Arms (2)

aqueous suppressant

aqueous suppressant treated

aqueous outflow

aqueous outflow treated

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

120 glacuoma patients

You may qualify if:

  • Age: 30 years or older.
  • Diagnosis: confirmed open-angle glaucoma in at least one eye:
  • glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
  • glaucomatous optic disc cupping
  • agreement between two baseline exams for reliability
  • Best corrected visual acuity at least 20/60 in at least one eye.
  • Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Limitations and Caveats

Small number of subjects at final endpoint, participation number various by analysis and date

Results Point of Contact

Title
Alon Harris
Organization
Indiana University
alharris@indiana.edu
3170278-0177

Study Officials

  • Alon Harris, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 4, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 27, 2014

Results First Posted

January 27, 2014

Record last verified: 2014-01

Locations

US(1)