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 | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | Ocular hypertension |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
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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 describe the safety of polyquaternium-preserved DuoTrav APS dosed once daily for 12 months, 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. 2. Patients diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or confirmed ocular hypertension who would benefit from a fixed combination medication, in the opinion of the Investigator. NOTE: Patients are eligible if they are insufficiently responsive to an intraocular pressure lowering monotherapy, as documented in the patients' medical records. NOTE: Patients may currently be treated with unfixed or fixed combination IOPlowering medications. Patients may be eligible if they are insufficiently responsive or intolerant to a combination therapy (fixed or unfixed), excluding combination therapies containing a prostaglandin analogue and a beta-blocker. Patients may be eligible if they are well controlled on a combination therapy (fixed or unfixed) containing a prostaglandin analogue and a beta-blocker. 3. Patients currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering medication. 4. Only patients who satisfy all Informed Consent requirements may be included in the study. Section 18.4. lists the required elements of the Informed Consent, the origins of which are derived from the Declaration of Helsinki, amended in 2002 (see Section 18.3.). The Informed Consent documents must be executed as follows: 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. Only patients who are able to read, sign, and date the informed consent can be enrolled. The Informed Consent form signed by patients must have been approved by the IRB/IEC for the current study.
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E.4 | Principal exclusion criteria |
Exclusion Criteria Patients demonstrating any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article, safe participation in this study, or affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude patients from enrollment in this study: Pregnancy: 1. 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 Screen/Enrollment 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: o Hormonal – oral, implanted, topical, or injected contraceptives; o Mechanical – spermicide in conjunction with a barrier such as a condom or diaphragm or; IUD
Exclusion Criteria related to the disease condition being investigated (open-angle glaucoma or ocular hypertension):
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 (see Section 18.1.3.). 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 (see Section 9.4.6. for details).
Exclusion Criteria related to ocular/systemic patient history or current ocular condition in either eye:
6. History of (i.e., within the last 3 months), or current chronic, recurrent, or severe ocular nfection, inflammation or 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 in the opinion of the Investigator. 7. History of ocular trauma within the past 6 months. 8. Intraocular laser 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). See Section 9.4.9. for details on the procedure. 11. 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. 12. Any abnormality preventing reliable applanation tonometry. 13. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent. 14. History of or current 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) that would preclude the safe administration of a topical beta-adrenergic blocking agent. 15. History of spontaneous or current hypoglycemia or uncontrolled diabetes. 16. History of or current severe allergic rhinitis and bronchial hyper reactivity. 17. History of or current corneal dystrophies.
Exclusion Criteria related to systemic or ocular medications:
18. History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, beta-adrenergic blocking agents, or to any components of the study medication. For listings of additional formulation components present in the study medication, see the Clinical Investigator’s Brochure for DuoTrav APS. 19. Use of any additional topical or systemic ocular hypotensive medication during the study.
Others:
20. Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Screening Visit. 21. Patients not willing to complete all required study visits. 22. 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. 23. Additionally, in rare circumstances, a patient may be declared ineligible by the Alcon Medical Monitor for a valid medical reason [e.g., patients with a medical condition (systemic or ophthalmic) not specified above that may preclude the safe administration of test article or safe participation in this study, or that may affect the results of this study].
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E.5 End points |
E.5.1 | Primary end point(s) |
Long-term safety of polyquaternium-preserved DuoTrav APS dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension
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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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
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 | 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.8.4.1 | 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 | 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 |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |