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Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

NCT03896633 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2023-05-09

Study results available
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Summary

The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM

Conditions

  • Glaucoma
  • Open Angle or Ocular Hypertension

Interventions

DRUG

brinzolamide 1% ophthalmic suspension

brinzolamide 1% ophthalmic suspension

DRUG

Azopt 1%

Azopt 1%, RLD

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Lindsey Mathew · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2018-11-17
Completion
2018-11-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896633 on ClinicalTrials.gov