Efficacy and safety assessment of T4032 versus Lumigan® 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
- EUCTR2017-000846-23-FR
- Lead Sponsor
- aboratoires THEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 434
At Screening Visit (D-42):
-Informed consent signed and dated.
-Patient aged =18 years old.
-Both eyes with 500 µm = central corneal thickness = 600 µm.
-Both eyes with diagnosed open-angle glaucoma or ocular hypertension, initially treated and controlled (including IOP = 18 mmHg) for at least 6 months by any prostaglandin monotherapy.
-Both eyes with IOP = 18 mmHg.
At Randomisation Visit (D1) at 8:00:
-Both eyes with 22 mmHg = IOP < 34 mmHg and 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 161
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 273
Ophthalmic Exclusion Criteria in AT LEAST ONE EYE:
-Fundus examination not performed or not available within 12
months.
-Visual field not performed or not available within 12 months.
- Significant worsening according to the two last visual fields (at
least 6 months between the two visual fields).
-Advance stage of glaucoma, defined by at least one of the following criteria:
- Absolute defect in the ten degrees central point of the visual field.
- Severe visual field loss: MD < -18 dB.
-Risk of visual field worsening as a consequence of participation in the study according to the investigator’s best judgement.
-History of non-responder to bimatoprost therapy.
-Far Best Corrected Visual Acuity = + 0.7 Log Mar (e.g., = 0.2 in decimal value or = 20/100 Snellen equivalent or = 50 ETDRS letters).
-History of trauma, infection, clinically significant inflammation
within the 3 previous months.
-Ongoing or known history of ocular allergy and/or uveitis
and/or viral infection.
-Clinically significant or progressive retinal disease (e.g. retinal
degeneration, diabetic retinopathy, retinal detachment).
-Presence of at least one severe objective sign among the following:
-Conjunctival hyperaemia (Grade 5 / McMonnies
scale).
-Superficial punctate keratitis (Grade 4/5 / Oxford
scale).
- Blepharitis (Grade 3 / 0-3 scale).
- Severe dry eye as assessed by the investigator.
- Corneal ulceration.
-Any palpebral abnormality incompatible with a good
examination.
-Any other abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination, fundus examination.
Regarding Systemic/non Ophthalmic Exclusion Criteria, Specific Exclusion Criteria Regarding Childbearing Potential Women, Exclusion Criteria Related to General Conditions and Exclusion Criteria Related to Previous and Concomitant Treatments (Medications/Non-Medicinal Therapies/Procedures) please refer to the study protocol in page 28.
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 T4032 unpreserved eye drops compared to Lumigan® 0.01% in terms of efficacy. ;Secondary Objective: To evaluate the safety and efficacy of T4032 versus Lumigan® 0.01%.;Primary end point(s): Change from baseline (Day 1) to Week 12 in IOP at the three time points (8:00 am; 10:00 am; 4:00 pm) in the worse eye. ;Timepoint(s) of evaluation of this end point: 3 timepoints (8:00 am; 10:00 am; 4:00 pm) at Visit#2 (Day 1), Visit 3 (week 6) and visit 4 (week 12)
- Secondary Outcome Measures
Name Time Method