E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open Angle Glaucoma or Ocular Hypertension |
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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 |
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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 |
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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 compare the efficacy and safety of Travoprost APS to TRAVATAN Solution both dosed once-daily in the evening, in patients with open-angle glaucoma or ocular hypertension. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients, of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertersion. Diagnosis of ocular hypertension in treatment-naïve patients should be documented as elevated IOP (i.e., >=21 mmHg) at multiple points within the past year. 2. Patients not currently on any IOP-lowering medication or currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering monotherapy (not a fixed combination product) medication. 3. Patients must meet the following IOP entry criteria in at least one eye at Eligibility Visits 1 & 2: Mean IOP >= 24 mmHg at the 09:00 time point, and Mean IOP >= 21 mmHg at the 11:00 and 16:00 time points. The mean IOP in either eye at Screening or Eligibility must not be greater than 36 mmHg at any time point. The mean IOP is the average of at least two IOP measurements in the same eye. The same eye(s) must qualify at all qualifying time points. 4. Only patients who satisfy all Informed Consent requirements may be included in the study. |
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E.4 | Principal exclusion criteria |
1. Females of childbearing potential (those who are not surgically sterilized or at least two years postmenopausal) 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. 2.Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension. 3.Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) in either eye, as measured by gonioscopy. 4.Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye. 5.Patients with severe central visual field loss in either eye. 6.History of, or current chronic, recurrent, or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study. 7.History of ocular trauma within the past 6 months. 8.Intraocular surgery within the past 6 months. 9.Ocular laser surgery within the past 3 months. 10.Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal). 11.Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination. 12.History of, or current clinically relevant (in the opinion of the Investigator) or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. 13.Any abnormality preventing reliable applanation tonometry. 14.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. 15.History of severe or serious hypersensitivity to prostaglandin drugs or their analogues or to any components of the study medications. 16.Patients who are unwilling to remove their contact lenses prior to instillation of the study medication and to leave them out for a minimum of 15 minutes following instillation before reinserting the lenses for the duration of the study. 17.Patients who are unable, in the opinion of the Investigator, to safely discontinue use of all IOP-lowering medication(s) during the washout period. 18.Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may affect IOP, including, but not limited to, betaadrenergic blocking agents. 19.Use of any additional topical or systemic ocular hypotensive medication during the study. 20.Patients who cannot safely discontinue all 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 the Eligibility 1 Visit, and must be able to remain off these medications for the duration of the study. 21.Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit 22.Patients not willing to complete all required study visits. E |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy: Mean IOP Safety: Adverse Events |
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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 | 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 | 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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 |
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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 | 0 |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |