Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UDin Ocular Hypertensive or Glaucomatous Patients.

aboratoires THEA0 个研究点目标入组 500 人开始时间: 2020年12月7日最近更新: 2023年7月18日

研究概览

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•1. Informed consent signed and dated
•AT SCREENING (Visit #1):
•2. Patient aged =18 years old
•3. Both eyes with a central corneal thickness assessment =500 µm and =600 µm assessed within 6 months or during the Screening visit
•4. Both eyes with diagnosed ocular hypertension or open angle glaucoma (primary open-angle, pseudoexfoliative or pigmentary glaucoma) currently treated with a first-line monotherapy (PGA or beta-blocker), insufficiently controlled in the opinion of the investigator, and requiring a dual therapy (bitherapy)
•AT RANDOMISATION VISIT (Visit #2):
•5. IOP =22 mmHg in both eyes at 08:00
•6. IOP asymmetry between eyes =4 mmHg at 08:00
•7. IOP <36 mmHg in both eyes at all time points (08:00, 10:00, 16:00)
•8. Patient having respected the wash out period of at least 28 days
•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 280
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 220

•1. Ophthalmic Exclusion Criteria in AT LEAST ONE EYE
•Patient experiencing at Screening visit or having experienced:
•1.1 Inability to safely discontinue use of IOP-lowering ocular medication for the specified wash-out period according to the investigator’s judgement
•1.2 Visual field not available within previous 6 months and not performed at the Screening visit
•1.3 History of narrow angle and/or angle closure glaucoma
•1.4 Advanced stage of glaucoma
•2. Systemic/non Ophthalmic Exclusion Criteria
•Patient experiencing AT Screening or Randomisation visits:
•2.1 Uncontrolled diabetes
•2.2 Overt cardiac failure, cardiogenic shock
•2.3 Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
•2.4 Heart rate <50 bpm and/or systolic arterial blood pressure =90 mmHg
•2.5 Presence or history of reactive airway disease (e.g bronchial asthma or severe chronic obstructive pulmonary disease)
•2.6 Any other history of, or active relevant systemic condition incompatible with the study or likely to interfere with the study results or the patient safety according to investigator’s judgement

发起方

aboratoires THEA