E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
primary open-angle glaucoma exfoliation glaucoma pigmentary glaucoma ocular hypertension |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035015 |
E.1.2 | Term | Pigmentary glaucoma |
|
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 | 10030043 |
E.1.2 | Term | Ocular hypertension |
|
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 | 10037118 |
E.1.2 | Term | Pseudoexfoliation glaucoma |
|
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 | 10036719 |
E.1.2 | Term | Primary 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 objective of this study is to compare the efficacy of brinzolamide 1.0% (Azopt) compared to placebo administered twice daily when added to travoprost 0.004%/timolol 0.5% fixed combination administered each morning. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the safety between the two treatment groups during randomized therapy. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Must have a clinical diagnosis of ocular hypertension, primary open-angle, exfoliation, or pigment dispersion glaucoma in at least one eye (study eye).
- Must have been treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations for a minimum of two weeks at Visit 1 and have an intraocular pressure of between 21 and 32 mm Hg inclusive in at least one eye and ≤ 32 mm Hg in both eyes at Visit 1.
- Must have an IOP between 19 and 32 mm Hg inclusive at the 8:00 AM measurement in at least one eye and ≤ 32 mm Hg at all time points in both eyes at Visit 2.
- Must have best corrected visual acuity of 6/30 (20/100 Snellen, 0.7 LogMAR) or better in each eye.
|
|
E.4 | Principal exclusion criteria |
- Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1.
- Women of childbearing potential
- Any clinically significant, serious, or severe medical or psychiatric condition.
- Participation in any other investigational study within 30 days prior to Visit 1.
- Known medical history of allergy or sensitivity to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator (sulfa or BAC allergy).
- Concomitant administration of an oral carbonic anhydrase inhibitor.
- Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 30 days prior to Visit 1 or an anticipated change in the dosage during the course of the study.
- History of bronchial asthma, or chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- A history of, or at risk for uveitis or cystoid macular edema (CME).
- History of ocular herpes simplex.
- Fuch’s corneal dystrophy, moderate to severe guttata, or a subjectively low endothelial cell count by slit lamp biomicroscopy.
- Use of contact lenses, unless patients agree to remove them prior to instillation of study medication and wait a minimum of fifteen minutes following drug instillation before re-inserting the lenses.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | Information not present in EudraCT |
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 |
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |