| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10030856 |
| E.1.2 | Term | Open-angle glaucoma |
|
| 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 statistical objective of this study is to demonstrate superior effect on diastolic ocular perfusion pressure of AZARGA (Brinzolamide 10 mg/ml/Timolol 5 mg/ml) Eye Drops Suspension relative to that of COMBIGAN (Brimonidine 20 mg/ml/Timolol 5 mg/ml) Eye Drops Solution |
|
| E.2.2 | Secondary objectives of the trial |
| The objectives of this study are to compare the short-term effects of AZARGA (Brinzolamide 10 mg/ml/Timolol 5 mg/ml) Eye Drops Suspension, and COMBIGAN (Brimonidine 20 mg/ml/Timolol 5 mg/ml) Eye Drops Solution on circadian ocular perfusion pressure, ocular blood flow, IOP and blood pressure in open-angle glaucoma patients. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Male or female patients 18 years of age or older diagnosed with open-angle glaucoma (with or without pseudoexfoliative component) in at least one eye and requiring more than one IOP-lowering medication.
2. Patients must meet the following IOP entry criteria in at least one eye:
• For the qualifying eye(s), the mean IOP must be ≥ 23 mmHg at least at one time
point and ≤ 32 mmHg at all time points at the Eligibility/Period 1 Baseline (24-hour
assessment) Visit
• The mean IOP in either eye at any time point during Screening, Safety and
Eligibility/Period 1 Baseline Visits must not be greater than 32 mmHg
3. Only patients who satisfy all informed consent requirements may be included in the study. Only patients who are able to read, sign and date the Informed Consent Form can be enrolled. The Informed Consent form signed by the patients MUST have been approved by the independent Ethics Committee (IEC) for this study.
The patient must read, sign, and date the Informed Consent document before any study related procedures are performed. The person who conducted the informed consent discussion must also sign and date the Informed Consent document. An original of the signed and dated Informed Consent document must be provided to the patient and one original signed document placed in the patient’s chart.
4. Patients must be able to discontinue use of all IOP-lowering medication(s) for a
minimum period of 3 days to 28 days prior to the Eligibility/Period 1 Baseline (24-hour
assessment) Visit and for 4 weeks between the treatment periods during the study. The investigator shall assess the minimum initial washout period based on the class of the patient’s current IOP-lowering medication.
5. Patients using topical ophthalmic and/or systemic non- IOP-lowering medications
(except for those listed in the Exclusion Criteria n°15) may be included in the study.
6. Patients must be willing to complete all required study visits. |
|
| E.4 | Principal exclusion criteria |
1. Female of childbearing potential (those who are not surgically sterilized at least 3
months prior to study start or who are at least two years post-menopausal) are excluded
from participation in the study if they meet any one of the following.
• They are currently pregnant, or
• They have a positive results on the urine pregnancy test at the Screening Visit or,
• They intend to become pregnant during the study period or,
• They are breast-feeding or,
• They are not using highly effective birth control measures:
− Hormonal – oral, implanted, topical, or injected contraceptives;
− Mechanical – spermicide in conjunction with a barrier such as a condom or
diaphragm or IUD
Note: All females of childbearing potential must consent to a urine pregnancy test upon entering and exiting the study.
Note: Instruct females of childbearing potential to immediately inform the investigator if they become pregnant during the study. Should this occur, the investigator shall immediately contact the sponsor.
Note: For non-sexually active females, abstinence may be regarded as an adequate
method of birth control; however if the patient becomes sexually active during the study, she must agree to use adequate birth control methods as defined above for the remainder of the study.
2. Patients with any form of glaucoma other than open-angle glaucoma (with or without pseudoexfoliative component).
3. Patients with severe central visual loss in either eye defined as sensitivity ≤ 10dB in at least 2 of the 4 visual field test points closest to the point of fixation.
4. Patients with angle grade less than Grade III, as measured by gonioscopy. See
5. Patients with a cup/disc ratio greater than 0.8 in either eye.
6. Patients who wear contact lenses.
7. Patients who had previous intraocular surgery in the study eye(s) within 3 months
prior to the Screening Visit.
8. Patients who had previous glaucoma surgery in the study eye(s).
9. Patients with best corrected visual acuity worse than 0.6 logMAR score in either eye.
10. Patients who are currently on therapy or were on therapy with another investigational product within 30 days prior to the Screening Visit
11. Patients with diabetic retinopathy of any stage.
12. Patients who cannot safely discontinue the use of all glucocorticoid medication
administered by any route. Patients must have washed out of chronic glucocorticoids
for at least 4 weeks prior to the Screening Visit (period can be reduced to 2 weeks in
case of intermittent glucocorticoid therapy) and must be able to remain off these
medications for the duration of the study.
13. History of allergy or severe hypersensitivity to timolol maleate, carbonic anhydrase inhibitors, sulfonamide derivative, or to any components of the study medications in the opinion of the investigator. For listing of additional components present in the study medications, see the Clinical Investigator’s Brochure for AZARGA and the SPC for COMBIGAN
14. Cardiovascular diseases or uncontrolled hepatic or renal diseases that would require the use of medication as listed under exclusion criteria n°15 or would preclude the safe administration of a topical beta-blocker.
15. Concomitant systemic treatments with medications that could effect IOP, blood pressure or blood flow (e.g., beta-blockers, angiotensin converting enzyme inhibitors, calcium antagonists, alpha blockers, platelet inhibitors, anti-coagulant)
16. Recent (within 4 weeks of the Screening Visit) use of high–dose (> 1 gram daily)
salicylate therapy. Rare instances of drug interactions have occurred with high-dose
salicylate therapy and patients treated with oral carbonic anhydrase inhibitors.
17. Bronchial asthma or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
18. Any abnormality preventing reliable tonometry of either eye.
19 Any severe illness or condition which would make the patient, in the opinion of the
investigator, unsuitable for the study.
20. The Alcon Medical monitor may declare any patient ineligible for a valid medical
reason. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Diastolic Ocular Perfusion Pressure |
|
| 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 | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| 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 | No |
| E.8.1.4 | Double blind | Yes |
| 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.8.3 |
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 | No |
| 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 | Information not present in EudraCT |
| 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
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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