NCT00273442

Brief Summary

To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

5 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

November 1, 2005

Completed
2 months 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
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 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

Ocular HypertensionOpen-Angle GlaucomaExfoliation SyndromeGlaucoma, Pigmentary

Interventions

timolol maleateDRUG
dorzolamide/timolol maleate fixed combinationDRUG

Eligibility Criteria

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

You may qualify if:

  • adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
  • the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
  • visual acuity should be 20/200 or better in each eye

You may not qualify if:

  • contraindications to study drugs
  • anticipated change in systemic hypotensive therapy during the trial
  • use of any corticosteroids by any route in the three months immediately prior to Visit 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Little Rock Eye Clinic

Little Rock, Arkansas, 72205, United States

Location

Omni Eye Services

Atlanta, Georgia, 30342, United States

Location

Midwest Eye Center

Bourbonnais, Illinois, 60914, United States

Location

Mark J. Weiss, MD

Tulsa, Oklahoma, 74104, United States

Location

Glaucoma Consultants & Center for Eye Research

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-AngleExfoliation Syndrome

Interventions

Timololdorzolamide

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucomaIris DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • William C. Stewart, MD

    Pharmaceutical Research Network, LLC

    STUDY DIRECTOR

  • Mark J. Weiss, MD

    PRINCIPAL INVESTIGATOR

  • Douglas G. Day, MD

    Omni Eye Services

    PRINCIPAL INVESTIGATOR

  • Sriram Sonty, MD, FACS

    Midwest Eye Center

    PRINCIPAL INVESTIGATOR

  • J. Charles Henry, MD

    Little Rock Eye Clinic

    PRINCIPAL INVESTIGATOR

  • Elizabeth D. Sharpe, MD

    Glaucoma Consultants & Center for Eye Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

November 1, 2005

Study Completion

April 1, 2007

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations

US(5)