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: Eye gel in single-dose container
INN or Proposed INN: BIMATOPROST
CAS Number: 155206-00-1
Current Sponsor code: T4032
Concentration
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 273
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, Czech Republic, Estonia, France, Germany, Greece, Italy, Latvia, Lithuania, Poland, Spain, Tunisia, Ukraine, United Kingdom
Contacts
Public ContactClinical department
Laboratoires THEA
Outcome results
None listed