NCT01514734

Brief Summary

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 21, 2013

Completed
Last Updated

October 21, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

January 18, 2012

Results QC Date

August 15, 2013

Last Update Submit

August 15, 2013

Conditions

Glaucoma

Keywords

Primary open-angle glaucomaOcular hypertensionPigment dispersion glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).

    Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

    8 weeks

Study Arms (1)

AZARGA

EXPERIMENTAL

Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks

Drug: Brinzolamide/timolol maleate fixed combination

Interventions

Brinzolamide/timolol maleate fixed combinationDRUG

Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.

Also known as: AZARGA®
AZARGA

Eligibility Criteria

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

You may qualify if:

  • years of age or older.
  • Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
  • Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
  • IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
  • Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
  • IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.

You may not qualify if:

  • History of ocular herpes simplex.
  • Abnormality preventing reliable applanation tonometry.
  • Corneal dystrophies.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
  • Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
  • Progressive retinal or optic nerve disease from any cause.
  • Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
  • Pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

São Paulo, 11045-140, Brazil

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleOcular Hypertension

Interventions

brinzolamideAzarga

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Doug Hubatsch, Global Brand Leader, Medical Affairs
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Doug Hubatsch, M.Sc.

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 23, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 21, 2013

Results First Posted

October 21, 2013

Record last verified: 2013-08

Locations

BR(1)