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Clinical Trials/NCT00300079
NCT00300079CompletedPhase 4

A Multiple-Dose Study of the IOP-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% When Added to a PGA as Adjunctive Therapy Over a 24 Hour Period in Patients With Glaucoma or Ocular Hypertension

Alcon Research1 site in 1 country30 target enrollmentStarted: September 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
IOP-lowering at 8 and 16 weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Primary open angle glaucoma or ocular hypertension patients

Exclusion Criteria

  • •Women of childbearing potential
  • •History of bronchial asthma, or severe chronic obstructive pulmonary disease
  • •Presence of acute glaucoma

Outcomes

Primary Outcomes

IOP-lowering at 8 and 16 weeks

Secondary Outcomes

  • Safety throughout the 16 weeks of the study

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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