NCT00273455

Brief Summary

To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

3 active sites

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

January 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

First QC Date

January 6, 2006

Last Update Submit

November 18, 2008

Conditions

Open-Angle Glaucoma

Interventions

bimatoprost 0.03%DRUG
dorzolamide 2%/timolol maleate 0.5% fixed combinationDRUG
placeboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
  • on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
  • visual acuity should be 20/200 or better in each eye

You may not qualify if:

  • historical failure to respond to topical beta-blockers in a clinically meaningful manner
  • any contraindication to study medications
  • any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Taustine Eye Center

Louisville, Kentucky, 40217, United States

Location

Glaucoma Consultants & Center for Eye Research, PA

Mt. Pleasant, South Carolina, 29464, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

dorzolamideTimolol

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • William C. Stewart, MD

    Pharmaceutical Research Network, LLC

    STUDY DIRECTOR

  • Robert D. Williams, MD

    Taustine Eye Center

    PRINCIPAL INVESTIGATOR

  • Robert H. Stewart, MD

    Houston Eye Associates

    PRINCIPAL INVESTIGATOR

  • Elizabeth D. Sharpe, MD

    Glaucoma Consultants & Center for Eye Research, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

January 1, 2006

Study Completion

May 1, 2007

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations

US(3)