NCT01518244

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2011

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 4, 2014

Completed
Last Updated

August 7, 2015

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

January 23, 2012

Results QC Date

February 25, 2014

Last Update Submit

July 17, 2015

Conditions

Glaucoma

Keywords

Primary open angle-glaucomaOcular hypertensionPigment dispersion glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8

    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

    Baseline, Week 8

Secondary Outcomes (1)

  • Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8

    Week 8

Study Arms (1)

AZARGA®

EXPERIMENTAL

Brinzolamide/timolol maleate fixed combination, 1 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
Also known as: AZARGA®
AZARGA®

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
  • On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
  • IOP considered safe in both eyes in order to 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:

  • Presence of other primary or secondary glaucoma.
  • History of ocular herpes simplex.
  • Any 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 Screening Visit.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
  • 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 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

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

    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 23, 2012

First Posted

January 25, 2012

Study Start

December 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 7, 2015

Results First Posted

April 4, 2014

Record last verified: 2014-02