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Trial NCT00486252

Resource URI: http://static.linkedct.org/resource/trials/NCT00486252
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/63128>
linkedct:biospec_retention None Retained
linkedct:brief_title Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN®
linkedct:condition <http://static.linkedct.org/resource/condition/5293>
linkedct:condition <http://static.linkedct.org/resource/condition/9169>
linkedct:criteria Inclusion Criteria: - Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure)  21 mmHg at diagnosis). - Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure - Visual acuity (best corrected) equal to or better than 6/6 Exclusion Criteria: - closed/barely open anterior chamber angle or history of acute angle closure glaucoma. - history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention). - ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.) - other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:eligibility_sampling_method Non-Probability Sample
linkedct:eligibility_study_pop outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension
linkedct:end_date January 2008
linkedct:enrollment 996 (xsd:int)
linkedct:firstreceived_date June 12, 2007
linkedct:has_dmc No
linkedct:id NCT00486252
linkedct:intervention <http://static.linkedct.org/resource/intervention/100218>
rdfs:label Trial NCT00486252
linkedct:lastchanged_date November 4, 2009
linkedct:lead_sponsor_agency Pfizer
linkedct:nct_id NCT00486252
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 1 (xsd:int)
linkedct:official_title Non Interventional Study in Patients With Open Angle Glaucoma and/or Ocular Hypertension Treated With XALATAN® (Latanoprost) as First-Line Monotherapy and as Second-Line Monotherapy After Beta-Blockers Therapy Failure
linkedct:org_study_id A6111138
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/47116>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/624>
foaf:page <http://clinicaltrials.gov/show/NCT00486252>
linkedct:phase Phase 4
linkedct:primary_completion_date January 2008
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/58104>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/17604>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/82579>
linkedct:source Pfizer
linkedct:start_date June 2007
linkedct:study_design Case-Only, Prospective
linkedct:study_type Observational
linkedct:summary The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months
rdf:type linkedct:trials
linkedct:verification_date November 2009