Clinical trial NCT00140062: Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.
Official title: A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ocular Hypertension
Glaucoma, Open-Angle
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
* IOP of \> 21 mm Hg on current treatment

Exclusion Criteria:

* Any previous or current treatment with latanoprost or other prostaglandin analogues

Primary outcomes:
measure: Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.
Secondary outcomes:
measure: Safety and the health care utilization in the two treatment groups over 36 months.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Lahti
country: Finland
facility: Pfizer Investigational Site
city: Rovaniemi
country: Finland
facility: Pfizer Investigational Site
city: Seinajoki
country: Finland
facility: Pfizer Investigational Site
city: Tammisaari
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: JÃ¶nkÃ¶ping
country: Sweden
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Kristianstad
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Ludvika
country: Sweden
facility: Pfizer Investigational Site
city: Molndal
country: Sweden
facility: Pfizer Investigational Site
city: Nacka
country: Sweden
facility: Pfizer Investigational Site
city: Norrkoping
country: Sweden
facility: Pfizer Investigational Site
city: Norrkoping
country: Sweden
facility: Pfizer Investigational Site
city: NykÃ¶ping
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Seinajoki
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Sundsvall
country: Sweden
facility: Pfizer Investigational Site
city: TÃ¤by
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: