Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UDin Ocular Hypertensive or Glaucomatous Patients.
- Conditions
- Primary open-angle glaucoma or Ocular hypertensionMedDRA version: 20.0Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]
- Registration Number
- EUCTR2020-003979-18-BG
- Lead Sponsor
- aboratoires THEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 500
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of T4030 (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1%) with Ganfort UD (unpreserved fixed combination of bimatoprost 0.03% and timolol 0.5% eye drops) in terms of efficacy.;Secondary Objective: To evaluate the efficacy and safety of T4030 versus Ganfort UD.;Primary end point(s): 1. The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP at 08:00 in the study eye.<br><br>;Timepoint(s) of evaluation of this end point: week 12 <br>
- Secondary Outcome Measures
Name Time Method