Primary open-angle glaucoma or 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: unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1%
Product Code: T4030
Pharmaceutical Form: Eye gel in single-dose container
INN or Proposed INN: BIMATOPROST
CAS Number:
Sponsors
Laboratoires THEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: week 12 ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)Safety and tolerability endpoints: Frequency distribution and change from Baseline (Day 1) in each eye at week 6 and week 12: • for the conjunctival hyperaemia on McMonnies scale • for each ocular sign at slit lamp • for CFS on Oxford grading scale Frequency distribution of patients with clinically significant appearance and/or worsening of ocular symptom(s) throughout the day and/or upon instillation - Far Best-Corrected Visual Acuity (BCVA) expressed in LogMAR - Ocular tolerance assessed by the investigator - Ocular tolerance assessed by the patient - Ocular and systemic treatment-emergent adverse events (TEAE), serious TEAE, drug-related TEAE, TEAE leading to premature IMP discontinuation by System Organ Class (SOC) and Preferred Term (PT). - Cardiovascular parameters (heart rate and blood pressure) 2)Patient questionnaire outcome: Scores at Week 6 and Week 12 as assessed by the patient in the quality of life questionnaires (TSS-IOP Questionnaire). 3)efficacy endpoints: Change from Baseline (Day 1) to Week 12 in IOP at 10:00, 16:00 in the study eye Change from Baseline (Day 1) to Week 12 in mean diurnal IOP in the study eye Change from Baseline (Day 1) to Week 12 in IOP at three time points (08:00, 10:00, 16:00) in the contralateral eye Change from Baseline (Day 1) to Week 12 in mean diurnal IOP in the contralateral eye Change from Baseline to Week 6 in IOP at three time points (08:00; 10:00; 16:00) in the worse eye and in the contralateral eye Efficacy assessed by the investigator;Timepoint(s) of evaluation of this end point: week 6 and week 12 | — |
Countries
Belgium, Bulgaria, France, Hungary, India, Italy, Poland, Russian Federation, Spain, Ukraine, United Kingdom
Contacts
Public ContactResearch and Development Department
Laboratoires THEA
Outcome results
None listed