NCT01722604

Brief Summary

The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

June 9, 2021

Completed
Last Updated

May 9, 2023

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

November 5, 2012

Results QC Date

May 14, 2021

Last Update Submit

May 7, 2023

Conditions

GlaucomaOpen Angle or Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP) at Week 12

    Week 12

Secondary Outcomes (1)

  • Change in Intraocular Pressure (IOP) From Baseline to Week 12

    Baseline, Week 12

Study Arms (2)

Azopt 1% ophthalmic suspension

ACTIVE COMPARATOR

Ophthalmic suspension

Drug: Azopt 1%

Brinzolamide 1% ophthalmic suspension

EXPERIMENTAL

ophthalmic suspension

Drug: brinzolamide 1% ophthalmic suspension

Interventions

brinzolamide 1% ophthalmic suspensionDRUG

brinzolamide 1% ophthalmic suspension

Brinzolamide 1% ophthalmic suspension
Azopt 1%DRUG

Azopt 1%, RLD

Azopt 1% ophthalmic suspension

Eligibility Criteria

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

You may qualify if:

  • Male and females 18 years of age or older,
  • diagnosed with primary open-angle glaucoma or ocular hypertension.

You may not qualify if:

  • Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
  • ocular hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US01

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

brinzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Daniel Donatello
Organization
Bausch & Lomb
Daniel.Donatello@bausch.com
(585) 338-5306

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 9, 2023

Results First Posted

June 9, 2021

Record last verified: 2021-06

Locations

US(1)