Safety And Efficacy Of Xalatan Delivered Using Either A Conventional Dropper Bottle or A Delivery Device

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00283764
First received: January 26, 2006
Last updated: December 7, 2006
Last verified: October 2006
  Purpose

Compare the antihypertensive efficacy of two methods for instilling Xalatan eyedrops


Condition Intervention Phase
Glaucoma, Open-Angle
Ocular Hypertension
Drug: Xalatan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Intra-ocular pressure (IOP) level in the study eye.

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

Estimated Enrollment: 712
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283764

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283764     History of Changes
Other Study ID Numbers: A6111086
Study First Received: January 26, 2006
Last Updated: December 7, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014