Evaluation of the therapeutic equivalence of latanoprost PK and Xalatan. Double blind randomized clinical trial in subjects affected by open angle glaucoma or intraocular hypertension. - Latanoprost 1/2007

• Conditions: Subjects affected by glaucoma or intraocular hypertension.; MedDRA version: 9.1Level: SOCClassification code 10015919

• Registration Number: EUCTR2008-000780-42-IT
• Lead Sponsor: PH&T SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adult subjects of either sex,
Subjects affected by unilateral or bilateral POAG or IOH,
IOP > 21 mm Hg at Randomization visit,
Subjects who have given written informed consent, consistent with local requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects affected by closed or slit like anterior chamber angle,
Positive history for acute angle closure,
Positive history of argon laser trabeculoplasty within 3 months prior screening (the unlasered eye could be enrolled in the study) or of any ocular filtering surgical intervention (the unoperated eye could be enrolled in the study),
Ocular surgery or ocular inflammation/infection in either eye within 3 months prior to screening,
Current use of contact lenses,
Best corrected visual acuity < 20/200,
Subjects previously treated with Latanoprost,
Subject concomitantly treated with hypotonic agents,
Known cardiac conduction defects,
Decompensate heart failure,
Reactive airway disease,
Liver impairment with transaminase levels >3x the upper limit of normal range,
Hypersensitivity to any of the components of the treatment medication,
Female subjects of child-bearing potential with a positive pregnancy test;
Female subjects who are nursing;
Impossibility to attend all the planned visits and/or to have all the tests foreseen by the protocol performed,
History of non-compliance, alcoholism or drug abuse,
Subjects having previously participated in this study or in a clinical trial of an investigational drug within the last 30 days prior to the Screening visit,
Subject has any condition which, in the opinion of the investigator, could interfere with the study results or be considered detrimental to the subject?s welfare.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified