E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
glaucoma, ocular hypertension |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10018307 |
E.1.2 | Term | Glaucoma and ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the non-inferiority of T4032 unpreserved eye drops compared to Lumigan® 0.01% in terms of efficacy. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and efficacy of T4032 versus Lumigan® 0.01%. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 34 mmHg and with asymmetry between eyes ≤ 3 mmHg. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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) |
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E.5.2 | 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. |
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E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 127 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Bulgaria |
Canada |
Czech Republic |
Estonia |
France |
Georgia |
Germany |
Greece |
Hungary |
Italy |
Latvia |
Lithuania |
Mauritius |
Poland |
Russian Federation |
Slovakia |
Spain |
Tunisia |
Ukraine |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |