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NCT00950690 Clinical Trial

Efficacy and Tolerability of Xalatan in Patients

Glaucoma Clinical Trial

— A6111128  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00950690
Other study ID # A6111128
Secondary ID A6111128
Status Completed
Phase
First received
Last updated
Start date July 2005
Est. completion date December 2007

Study information
Verified date February 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 1289
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xalatan 0.005% eye drops
ophthalmic solution dosed once daily for 3 months

Locations
Country Name City State
Egypt Pfizer Investigational Site Alexandria
Saudi Arabia Pfizer Investigational Site Jeddah
United Arab Emirates Pfizer Investigational Site Umm Al Quwain

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Egypt,  Saudi Arabia,  United Arab Emirates, 

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