Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00283764

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided 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, Open-Angle
Ocular Hypertension
Eye Diseases
Glaucoma processed this record on March 03, 2015