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Clinical Trials/NCT00283764
NCT00283764WithdrawnPhase 3

A Phase 3, 12-Week, Parallel-Design Study Comparing The Safety, Efficacy, and Ease Of Use Of Xalatan When Self-Administered By Subjects With Open-Angle Glaucoma Or Ocular Hypertension Using Either A Conventional Dropper Bottle Or A Forced-Flow Delivery Device

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 sitesStarted: January 30, 2006Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Sponsor
Primary Endpoint
Intra-ocular pressure (IOP) level in the study eye.

Study Overview

Brief Summary

Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops

Study Design

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

Eligibility Criteria

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

Inclusion Criteria

  • Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes

Exclusion Criteria

  • History of closed/barely open anterior chamber angle or a history of angle closure

Outcomes

Primary Outcomes

Intra-ocular pressure (IOP) level in the study eye.

Secondary Outcomes

  • Successful eyedrop self-deliveries
  • Ease of eyedrop administration
  • Change in safety assessments throughout the study period
  • Subject preference for the method of drop delivery

Investigators

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

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