glaucoma, ocular hypertension MedDRA version: 20.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Bimatoprost
Product Code: T4032
Pharmaceutical Form:
INN or Proposed INN: BIMATOPROST
CAS Number: 155206-00-1
Sponsors
Laboratoires THEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 421
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy secondary Endpoints: Change from baseline to Week 12 in IOP at the three time points (8:00, 10:00 and 16:00) in the contralateral eye. Others efficacy endpoints will be analysed: - Change from baseline to Week 6 in IOP at the three time points (8:00; 10:00; 16:00) in the worse eye and in the contralateral eye. - Efficacy assessed by the investigator. Safety Endpoints: -Conjunctival hyperaemia on McMonnies scale at Week 6 and Week 12. -Change from baseline of the conjunctival hyperaemia on McMonnies scale in 3 classes (improvement, no change, worsening) at Week 6 and Week 12. -Score of each ocular symptom throughout the day and the sum of these scores. -Score of each ocular symptom upon instillation and the sum of these scores. -Score of each ocular sign. -Corneal fluorescein staining (Oxford grading scheme). -Far Best Corrected Visual Acuity expressed in Log MAR. -Ocular tolerance assessed by the investigator. -Ocular tolerance assessed by the patient. -Ocular and systemic AE by System Organ Class and Preferred Term. ; Timepoint(s) of evaluation of this end point: Efficacy secondary Endppoints: Change from baseline to Week 12 in IOP at the three time points (8:00 am, 10:00 am and 4:00 pm) in the contralateral eye. Others efficacy endpoints will be analysed: - Change from baseline to Week 6 in IOP at the three time points (8:00 am; 10:00 am; 4:00 pm) in the worse eye and in the contralateral eye. - Efficacy assessed by the investigator. Safety Endpoints: Visit#2 (Day 1), Visit 3 (week 6) and visit 4 (week 12) | — |
Countries
Belgium, Bulgaria, Canada, Czech Republic, Estonia, France, Georgia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mauritius, Poland, Russian Federation, Slovakia, Spain, Tunisia, Ukraine, United Kingdom
Contacts
Public ContactClinical department
Laboratoires THEA
Outcome results
None listed