Efficacy and Tolerability of Xalatan in Patients (A6111128)

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Observational Study Assessing The Efficacy And Tolerability Of Xalatan™ In Patients With Open Angle Glaucoma And /Or Ocular Hypertension.

Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Efficacy data not collected or analyzed
  • Safety and tolerability of Xalatan assessed NA

Study Type

Observational

Enrollment (Actual)

1289

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Pfizer Investigational Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Pfizer Investigational Site
  • United Arab Emirates
      • Umm Al Quwain, United Arab Emirates
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adults with glauocma or ocular hypertension

Description

Inclusion Criteria:

  • Patient with ocular hypertension at least 22mg Hg
  • Patient must be over 18 years old

Exclusion Criteria:

  • None listed in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Drug - Xalatan 0.005% eye drops
Drug: Xalatan 0.005% eye drops
ophthalmic solution dosed once daily for 3 months
Other Names:
  • latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure
Time Frame: Screening, 10 days, 4 weeks and 12 weeks after beginning treatment
Intraocular pressure was measured at each visit
Screening, 10 days, 4 weeks and 12 weeks after beginning treatment
Humphrey Perimetry Visual Field
Time Frame: Visits 1 and 4
Analysis of visual field deficits for abnormalities.
Visits 1 and 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6111128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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