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NCT00140062 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00140062
Other study ID # 912-OPT-0091-156
Secondary ID
Status Completed
Phase Phase 4
First received August 29, 2005
Last updated April 4, 2008
Start date February 2002
Est. completion date April 2006

Study information
Verified date April 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 329
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• latanoprost 0.005% (Xalatan)

Locations
Country Name City State
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Kuopio
Finland Pfizer Investigational Site Lahti
Finland Pfizer Investigational Site Rovaniemi
Finland Pfizer Investigational Site Seinajoki
Finland Pfizer Investigational Site Tammisaari
Finland Pfizer Investigational Site Tampere
Finland Pfizer Investigational Site Turku
Sweden Pfizer Investigational Site Jönköping
Sweden Pfizer Investigational Site Karlstad
Sweden Pfizer Investigational Site Kristianstad
Sweden Pfizer Investigational Site Linkoping
Sweden Pfizer Investigational Site Ludvika
Sweden Pfizer Investigational Site Molndal
Sweden Pfizer Investigational Site Nacka
Sweden Pfizer Investigational Site Norrkoping
Sweden Pfizer Investigational Site Norrkoping
Sweden Pfizer Investigational Site Nyköping
Sweden Pfizer Investigational Site Orebro
Sweden Pfizer Investigational Site Seinajoki
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Sundsvall
Sweden Pfizer Investigational Site Täby
Sweden Pfizer Investigational Site Uppsala
Sweden Pfizer Investigational Site Uppsala

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Safety and the health care utilization in the two treatment groups over 36 months.
See also
  Status Clinical Trial Phase
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Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02792803 - A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma Phase 4
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Terminated NCT02801617 - Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension Phase 3
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Completed NCT02993445 - Effect of Alternate Therapies on Intraocular Pressure in Ocular Hypertension N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01995136 - Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A

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