Health Condition 1: H408- Other glaucoma
Conditions
Interventions
Intervention1: T4030 - Unpreserved fixed combination bimatoprost 0.01% and timolol 0.1% eye drops presented in unit dose.: Route of administration: - Ocular use.
The patient will instill in the conju
Sponsors
Laboratories THEA
IQVIA RDS India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.1. Informed consent signed and dated Obtained prior the initiation of any procedures AT SCREENING (Visit #1) 1.2. Patient aged >=18 years old 1.3. Both eyes with a central corneal thickness assessment >=500 µm and 1.4. 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): 1.5. IOP >=22 mmHg in in both eyes at 08:00 1.6. IOP asymmetry between eyes 1.7. IOP 1.8. Patient having respected the wash out period of at least 28 days.
Exclusion criteria
Exclusion criteria: Ophthalmic Exclusion Criteria in AT LEAST ONE EYE [2.1] Patient experiencing at screening visit or having experienced: 2.1.1 Inability to safely discontinue use of IOP-lowering ocular medication for the specified wash-out period according to the investigatorâ??s best judgement 2.1.2 Visual field not available within previous 6 months and not performed at the screening visit 2.1.3 History of narrow angle and/or angle closure glaucoma 2.1.4 Advanced stage of glaucoma defined by at least one of the following criteria: 2.1.4.1 Severe central visual field loss (i.e., sensitivity loss 10 dB or more in at least 2 of the 4 visual field test points closest to the point of fixation) 2.1.4.2 Severe visual field loss: MD 2.1.4.3 Risk of visual field worsening as a consequence of participation in the study according to the investigatorâ??s best judgement 2.1.5 Cup to disk ratio >0.8 (horizontal or vertical measurement) 2.1.6 Known history of non-response to bimatoprost and/or timolol Patient experiencing at Screening or Randomisation visits or having experienced: 2.1.7 Far Best Corrected Visual Acuity >=0.7 LogMar (e.g., 2.1.8 History of trauma, infection or clinically significant inflammation within the previous 3 months 2.1.9 Ongoing or known history of uveitis and/or viral infection 2.1.10 Ongoing ocular allergy 2.1.11 Clinically significant or progressive retinal disease (e.g. para-/central retinal degeneration, diabetic retinopathy, retinal detachment) 2.1.12 Presence of at least one severe objective sign among the following: 2.1.12.1 Conjunctival hyperaemia Grade 5 on the McMonnies scale 2.1.12.2 Corneal fluorescein staining (CFS) Grade 4 or 5 on the Oxford grading scale 2.1.12.3 Severe Blepharitis Score 3 using a 0-3 scale 2.1.13 Presence of severe dry eye as assessed by the investigator 2.1.14 Presence of corneal ulceration 2.1.15 Presence of palpebral abnormalities incompatible with a good examination 2.1.16 Any other abnormality preventing accurate assessment and/or clinically significant ocular disease, which could potentially deteriorate during the study e.g. reliable applanation tonometry measurement, visual field assessment, fundus examination Systemic/non-Ophthalmic Exclusion Criteria [2.2] Patient experiencing at Screening or Randomisation visits: 2.2.1 Uncontrolled diabetes 2.2.2 Overt cardiac failure, cardiogenic shock 2.2.3 Sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker 2.2.4 Heart rate 2.2.5 Presence or history of reactive airway disease (e.g bronchial asthma or severe chronic obstructive pulmonary disease) 2.2.6 Known or suspected hypersensitivity to one of the components of the IMP(s) (T4030, Ganfort® UD) or fluorescein and/or oxybuprocaine hydrochloride 2.2.7 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 investigatorâ??s judgement Specific Exclusion Criteria Regarding Ch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP at 08:00 in the study eye. The study eye is defined as the eligible eye with the highest IOP at baseline at 08:00. In case of no IOP difference between both eyes, the right eye will be considered as the study eye. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of T4030 versus Ganfort UD.Timepoint: 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 study eye and in the contralateral eye | — |
Countries
Belgium, Bulgaria, Czech Republic, France, Hungary, India, Italy, Poland, Russian Federation, Spain, Tunisia, Ukraine, United Kingdom
Contacts
Public ContactJinu Jose
IQVIA RDS (India) Private Limited
Outcome results
None listed