NCT01304264

Brief Summary

To evaluate whether add-on to prostaglandin therapy with twice a day (bid) dorzolamide is statistically superior to twice a day (bid) timolol with regard to increasing ocular blood flow

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

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

February 24, 2011

Last Update Submit

January 11, 2012

Conditions

Open Angle Glaucoma

Keywords

glaucoma, ocular, blood flow, fluctuations

Outcome Measures

Primary Outcomes (1)

  • Ocular Color Doppler Imaging

    Color Doppler Imaging * Nasal post ciliary artery (NPCA) * Temporal posterior ciliary artery (TPCA) * Ophthalmic artery (OA) * Central retinal artery (CRA)

    8 AM; 8 PM

Secondary Outcomes (1)

  • IOP, BP, OPP (mean, fluctuations, amplitude)

    8 AM-12AM-4PM-8PM

Study Arms (1)

combination topical glaucoma treatment

timolol or dorzolamide add on latanoprost monotherapy

Device: Color Doppler Imaging

Interventions

Color Doppler ImagingDEVICE

Color Doppler imaging (CDI) system for measurements of blood flow in the ophthalmic (OA), central retinal (CRA), and nasal (NPCA) and temporal (TPCA) posterior ciliary arteries. In each vessel, peak systolic velocity (PSV) and end diastolic velocity (EDV) were determined, and Pourcelot's resistive index will be calculated (RI = (PSV-EDV)/PSV).

Also known as: timololum maleate, dorzolamidum, latanoprostum
combination topical glaucoma treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Regular visitors of Eye Clinic of Lithuania University of Health Science hospital

You may qualify if:

  • Open angle glaucoma subjects receiving prostaglandin monotherapy in both eyes

You may not qualify if:

  • younger than 18 years old
  • women of child bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Clinic Lithuania Health Science Hospital Kaunas Clinics

Kaunas, 50009, Lithuania

Location

Biospecimen

No biospecimens will be retained

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Ingrida Januleviciene, MD

    Lithuania University of Health Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

LI(1)