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 |
E.1.2 | Term | Open angle glaucoma |
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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 |
E.1.2 | Term | Ocular hypertension |
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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 |
To assess the IOP-lowering efficacy at 9 am, 11 am and 4 pm of a fixed combination of Travoprost 0.004% / Timolol Maleate 0.5% dosed in the morning versus the same fixed combination dosed in the evening, in patients with open-angle glaucoma or ocular hypertension, who have an IOP insufficiently controlled (IOP ≥ 19 to ≤ 28 mmHg) by prior prostaglandin analogue monotherapy. |
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E.2.2 | Secondary objectives of the trial |
To compare the safety and tolerability of Travoprost 0.004% / Timolol Maleate 0.5% fixed combination, dosed in the morning versus the evening, during a 12 week treatment period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male or female adult patients over the age of 18 years 2.Open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension. 3.Current treatment with prostaglandin analogue monotherapy, IOP-lowering medication. 4.Meet the following IOP entry criteria in at least one treated eye (mean IOP); a.≥ 19 mmHg b.≤ 28 mmHg
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E.4 | Principal exclusion criteria |
1. Females of childbearing potential 2. Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudo-exfoliation component). 3. Current or previous therapy with another investigational agent, within 30 days prior to study entry. 4. History of chronic or recurrent severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), in either eye. 5. History of ocular trauma within the past six months in either eye 6. History of ocular infection or ocular inflammation within the past three months in either eye. 7. History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. 8. History of any other severe ocular pathology (including severe dry eyes), in either eye that would preclude the administration of a topical prostaglandin analogue. 9. History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication. 10. Intraocular surgery within the past six months 11. Ocular laser surgery within the past three months 12. Angle grade less than Grade 2 in either eye, as measured by gonioscopy (extreme narrow angle with complete or partial closure), assessed within the previous 12 months. 13. Cup/disc ratio greater than 0.80 in either eye, assessed within the previous six months. 14. Severe central visual field loss in either eye, defined as a sensitivity of ≤ 10 bB in at least two of the four visual field test points, closest to the point of fixation, assessed within the previous six months. 15. Unable to safely discontinue all IOP lowering medication, for a minimum period of 28 days prior to Baseline Visit. 16. History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease (e.g. sinus bradycardia, overt cardiac failure, greater than first degree atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled hypertension), which would preclude the safe administration of a topical beta-blocker. 17. History of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. 18. History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Intraocular pressure as measured at 9am, 11am and 4pm |
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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) | 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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
evening versus morning dose |
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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 | 7 |
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
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The end of the trial will be when the last patient completes 12 weeks of treatment with DuoTrav. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |