| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Open-angle Glaucoma or ocular Hypertension |
|
| 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 | 10030348 |
| E.1.2 | Term | Open angle 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.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To compare the IOP-lowering efficacy of morning or evening instillations of Travoprost/Brinzolamide, versus Travatan dosed in the evening, versus Azopt dosed in the morning and in the evening, in patients with open angle glaucoma or ocular hypertension. |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| Patients, of either sex and any race, 18 years of age or older, diagnosed with openangle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Patients inadequately controlled on a current stable (i.e., at least 4 weeks) IOP-lowering medication. Inadequately controlled is defined as having a mean IOP ≥ 18 mmHg in at least one eye during the Screening Visit. Patients must meet the following IOP entry criteria in at least one eye. For each qualifying eye, the mean IOP must be: ≥ 24 mmHg and ≤ 36 mmHg at the 9:00 time point at both Eligibility Visits 1 and 2; ≥ 21 mmHg and ≤ 36 mmHg at the 11:00 and 16:00 time points at both Eligibility Visits 1 and 2. The mean IOP in either eye at the Eligibility Visits 1 and 2 must not be greater than 36 mmHg at any time point. The same eye(s) must qualify at all qualifying time points at both Eligibility Visits 1 and 2. The mean IOP is the average of at least two IOP measurements in the same eye. Only patients who satisfy all Informed Consent requirements may be included in the study. Patients who wear contact lenses will be allowed to participate in the study provided that the contact lenses are removed before instillation of study medication, and that the patients wait a minimum of 15 minutes following drug instillation before re-inserting the lenses. Patients using non prescription and/or prescription topical ophthalmic and/or systemic medications not affecting IOP (except for those in the Exclusion Criteria) may be included in the study. Patients must be able to discontinue use of all IOP-lowering medication(s) for a minimum period of 5 days to 28 days prior to Eligibility Visit 1. The Investigator shall assess the minimum washout period based on the class of the patient’s current IOP-lowering medication. Patients willing to complete all required study visits. |
|
| E.4 | Principal exclusion criteria |
| Pregnancy: Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study if they meet any one of the following conditions: - They are currently pregnant or, - They have a positive result 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. Exclusion Criteria related to the condition being investigated: Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension.Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy (see Section 18.1.4.). Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye. Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of ≤ 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation. Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis). History of ocular trauma within the past 6 months. Intraocular surgery within the past 6 months.Ocular laser surgery within the past 3 months. Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients’ history and/or examination. History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment. Any abnormality preventing reliable applanation tonometry. History of, or current evidence of severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study. History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, CAIs or to any components of the study medications. For listings of additional formulation components present in the study medications, see the Clinical Investigator’s Brochure for Travoprost / Brinzolamide which includes the Summary of Product Characteristics for TRAVATAN and AZOPT. Less than 30 days on stable dosing regimen before the Screening Visit with any medications or substances administered by any route and used on a chronic basis that may affect IOP, including, but not limited to, beta-adrenergic blocking agents. Use of any additional topical or systemic ocular hypotensive medication during the study. Patients who cannot safely discontinue glucocorticoid medications administered by any route. Patients must have washed out of chronic glucocorticoid medications for at least 4 weeks, or of intermittent glucocorticoid medications for at least 2 weeks before Eligibility 1 Visit, and must be able to remain off these medications for the duration of the study. Recent (within 4 weeks of Eligibility 1 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 CAIs. Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Efficacy: Mean IOP
Key Secondary Efficacy: Mean Diurnal IOP
Secondary Efficacy: Percent change in IOP, IOP change from baseline, and number and percentage of patients with IOP <18 mmHg
Safety: Ocular Signs, Best-Corrected Visual Acuity, Fundus Parameters, Ocular Hyperemia, Adverse Event |
|
| 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 | 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Confronto Trav/Brinz vs Travatan vs Brinzolamide - same IMP used at different dosage |
|
| 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 50 |
| 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 | 6 |
| E.8.9.1 | In the Member State concerned days | |
| 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 |
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