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Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00140062
Enrollment
329
Registered
2005-08-31
Start date
2002-02-28
Completion date
2006-04-30
Last updated
2008-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle, Ocular Hypertension

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.

Interventions

DRUGlatanoprost 0.005% (Xalatan)

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Safety and the health care utilization in the two treatment groups over 36 months.

Countries

Finland, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026