Efficacy and Safety assessment of T2345 unpreserved eyedrops versus Xalatan in ocular hypertensive or glaucomatous patients. - ND

• Conditions: ocular hypertensive or glaucomatous patients; MedDRA version: 9.1Level: LLTClassification code 10030043

• Registration Number: EUCTR2009-011157-41-IT
• Lead Sponsor: ABORATORIES THEA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients will be eligible for inclusion if all these criteria are respected: At Selection Visit: - Signed and dated informed consent, - Male or female aged from ≥ 18 to ≤ 90 years old, - Association of the following criteria for the eligible eye(s): - Chronic primary open angle glaucoma or chronic ocular hypertension - Already treated and controlled (since at least one year) by a monotherapy of Xalatan defined by: Stable IOP (≤ 18 mmHg), And Stable visual field defined by two available visual field: the penultimate visual field performed within the last 18 months the last visual field performed within the last 6 months and with an interval of at least 6 months between both visual fields. - Corneal thickness ≥ 510 Mm and ≤ 560 Mm. At Inclusion Visit: - IOP: IOP < 34 mmHg in BOTH eyes And IOP ≥ 22 mmHg in the eligible eye(s).
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

Ophthalmic non-inclusion criteria (in either eye) - Any secondary ocular hypertension. - Any severe glaucoma defined by study . - BCVA minor or equal to 1/10. - Aphakia. - Known history of ocular allergy and/or blepharitis and/or uveitis, traumatism, infection, ocular inflammation within the 3 months before the selection Visit, refractive surgery. - Severe dry eye. - Any abnormality preventing accurate assessment. Systemic/non ophthalmic non-inclusion criteria - General history: Non controlled asthma, Any medical or surgical history, disorder or disease and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study. - Known allergic hypersensitivity history to one of the components of the study medications or to test products. Specific non-inclusion criteria for women - Pregnancy, lactation, women without an effective method of contraception or women not hysterectomised, menopaused or surgically sterilized. Non-inclusion criteria related to general conditions - Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent. - Non compliant patient and/or relatives. - Participation in another clinical study within the last 3 months. - Already included once in this study. - Ward of court. - Patient not covered by the Social Security scheme when existing in the concerned country (NA in Italy).

Study & Design

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