E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction |
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E.1.1.1 | Medical condition in easily understood language |
Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | 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 |
The primary objective of this study is to evaluate the efficacy of the generic Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops suspension AZAD Pharma AG (test product) in lowering intra-ocular pressure (IOP) when compared to Brinzolamide 10 mg/ml + Timolol 5mg/ml eye drops suspension product Azarga® (reference product, Alcon Ltd). |
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E.2.2 | Secondary objectives of the trial |
1. To compare the tolerance of the test and reference products using a ocular comfort level score. 2. To compare the levels of conjunctival hyperaemia induced by test product and reference product. 3. To evaluate the general safety of the test product compared to the reference product. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Elevated IOP / primary open angle glaucoma (irideocorneal angle > 30°) in at least one eye: IOP pre-treatment (measured at approx. 8 am, 10 am and 4 pm) must be equal or higher than 22 mmHg, and equal or lower to 35 mmHg (untreated, i.e. naïve or after washout).
2. Not on any ophthalmic pressure-lowering medication, or in the condition not to suffer an untoward effects by withdrawal from current pressure-lowering medications for the washout period(s).
3. No ocular trauma, surgery, inflammation or infection, no corneal foreign body in the previous 3 months.
4. No clinically significant or progressive retinal disease as determined by dilated peripheral retinal examination done at screening.
5. No concomitant use of any topical ophthalmic medication other than artificial tears.
6. No ocular glucocorticoids in the previous 3 months. |
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E.4 | Principal exclusion criteria |
1. Visual acuity of less than distance Snellen 20/100 corresponding to decimal 0.20 or 0.70 logMAR in either eye.
2. Evidence of acute ocular infection, corneal foreign body, or ocular inflammation.
3. Previous significant ocular trauma, laser or incisional surgery within 3 months of the screening visit.
4. Any corneal abnormalities preventing reliable applanation tonometry.
5. Patients with risk of angle closure or evidence of acute, intermittent or chronic angle closure.
6. Types of glaucoma other than POAG with glaucomatous optic disc morphology or glaucoma visual field defect such as pigmentary or pseudo-exfoliative glaucoma.
7. Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination.
8. History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis) in one or both eyes.
9. Traumatic cataract surgery with an open posterior capsule or any patient with an anterior chamber intraocular lens implant or aphakia
10. Pregnant or nursing women.
11. History of drug or alcohol abuse within the last 6 months.
12. A history of hypersensitivity to Brinzolamide, Timolol, sulphonamides or any component in the formulation of the products being tested.
13. Patient with history of severe renal insufficiency (Creatinin Clearance <30ml/min) or hyperchloremic acidosis.
14. Patients with reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
15. Patients with sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock.
16. Patients with severe allergic rhinitis.
17. Patients who have participated in another research study for an investigational drug within 30 days of the screening visit.
18. History of evidence of any medical condition that would, in the opinion of the investigator, make the patient unsuitable for the study.
19. Systemic medication that may alter IOP in the previous 30 days (i.e. beta-blockers, Calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, prostaglandins etc.) or not expected to continue the current treatment with these medical products on a stable regimen for 30 days prior to the study and during the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is non-inferiority of test product when compared with reference product, with respect to the differences in the mean diurnal IOP measured at approximately 8 am, 10 am and 4 pm in the study eye between Day 1 (baseline, before treatment) and Day 22 (under treatment). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Diurnal IOP measured at approximately 8 am, 10 am and 4 pm in the study eye between Day 1 (baseline, before treatment) and Day 22 (under treatment). |
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E.5.2 | Secondary end point(s) |
a) Ocular tolerance: - Difference between the investigational products with respect to ocular comfort score at baseline Day 1 and Day 22 - Difference between investigational products with respect to conjunctival hyperaemia at baseline Day 1 and Day 22
b) Safety: Difference between investigational products with respect to general safety as assessed by occurence of adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 (baseline) and Day 22 (under treatment) |
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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 | No |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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End of trial is Las Visit of Last Subject LVLS |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |