Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.
- Conditions
- Glaucoma, 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
- EUCTR2017-002823-46-BE
- Lead Sponsor
- aboratoires THÉA; Research and Development Department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 143
At Screening Visit:
1.1. Informed consent signed and dated
1.2. Patient aged =18 years old
1.3. 500 µm = central corneal thickness = 600 µm in both eyes
1.4. Both eyes with diagnosed open angle glaucoma or ocular
hypertension:
1.4.1 Initially treated and controlled for at least 6 months by dual
therapy of prostaglandin and timolol (fixed combination or not)
1.4.1.1. Both eyes with IOP = 18 mmHg
1.4.1.2. History of IOP insufficiently controlled with first-line monotherapy based on the following reasons:
• No sufficient IOP reduction
Or
• Significant IOP reduction but progression of glaucoma (target IOP not reached)
1.4.1.3. Justification of an add-on IOP reduction with a combination of prostaglandin and timolol (fixed or not) 6 months after the switch from monotherapy to dual therapy (bitherapy)
OR
1.4.2 Initially treated with first-line monotherapy for at least 6 months, insufficiently controlled and requiring a dual therapy (bitherapy)
At Randomisation Visit (Day 1) at 9h00:
1.5. Both eyes with 22 mmHg = IOP < 36 mmHg with asymmetry between eyes = 3 mmHg
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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71
Ophthalmic Exclusion Criteria in AT LEAST ONE EYE [2.1]
2.1.1 Funduscopy not performed or not available within 12 months
2.1.2 Visual field not performed or not available within 12 months
2.1.3 Advanced stage of glaucoma defined by at least one of the following criteria:
2.1.3.1 Absolute defect in the ten degrees central point of the visual field
2.1.3.2 Severe visual field loss : MD < -18 dB
2.1.3.3 Risk of visual field worsening as a consequence of participation in the study according to the investigator's best judgement
2.1.4 History of non-response to bimatoprost and/or timolol
2.1.5 Far Best Corrected Visual Acuity = +0.7 LogMar (e.g., =0.2 in decimal value or =20/100 Snellen equivalent or =50 ETDRS letters)
2.1.6 History of trauma, infection, clinically significant inflammation within the 3 previous months
2.1.7 Ongoing or known history of ocular allergy and/or uveitis and/or viral infection
2.1.8 Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment)
2.1.9 Presence of at least one severe objective sign among the following:
2.1.9.1 Conjunctival hyperaemia (Grade 5 / McMonnies scale)
2.1.9.2 Superficial punctate keratitis (Grade 4-5 / Oxford scale)
2.1.9.3 Blepharitis (Grade 3 / 0-3 scale)
2.1.10 Severe dry eye as assessed by the investigator
2.1.11 Corneal ulceration
2.1.12 Palpebral abnormalities incompatible with a good examination
2.1.13 Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination
Systemic/Non Ophthalmic Exclusion Criteria [2.2]
2.2.1 Uncontrolled diabetic patient
2.2.2 History of cardiac disorders (except controlled arterial hypertension)
2.2.3 Any ECG abnormalities considered clinically significant and/or contraindicating the prescription of Timolol (Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, or any relevant abnormalities) according to centralised medical review
2.2.4 Heart rate <50 bpm and/or systolic arterial blood pressure =90 mmHg
2.2.5 History of bronchopulmonary disorders (e.g. asthma, chronic obstructive pulmonary disease)
2.2.6 Known or suspected hypersensitivity to one of the components of the investigational product, run in treatment (sulphonamides) or auxiliary product (fluorescein, oxybuprocaine hydrochloride)
2.2.7 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 judgement
Specific Exclusion Criteria Regarding Childbearing Potential Women[2.3]
2.3.1 Pregnancy or breast feeding
2.3.2 Childbearing woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch, double-barrier – i.e. condom associated with spermicide) and is not surgically sterilised
Exclusion Criteria Related to General Conditions [2.4]
2.4.1. Alcohol addiction and heavy smoker according to the investigator's judgement.
2.4.2. Inability of patient to understand the study procedures or to give informed consent
2.4.3. Non-compliant patient (e.g. not willing to attend a visit; way of life interfering with compliance)
2.4.4. Participation in this study at the same time as another clinical study
2.4.5. Participation in this study within the 4 weeks after the end of a previous clinical st
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method