E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glaucoma de angulo abierto o hiperstensión ocular.
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 pigmentation in the trabecular meshwork in subjects that have been treated for at least two years with TRAVATAN 0.004% compared to subjects without exposure (or < 1 month) to prostaglandine analogue. |
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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, 50 years of age or older, diagnosed with open angle glaucoma (without pseudoexfoliation or pigment dispersion component) and require a trabeculectomy, who have dosed with TRAVATAN for at least 2 years or who have no (or less than 1 month) prior exposure to any topical, ocular prostaglandin analogue. 2. Only patients who satisfy all Informed Consent requirements may be included in the study. 3. 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 all of the following conditions: ?They are not pregnant and, ?They have a negative urine pregnancy test at the Screening Visit and, ?They are not breast-feeding and, ?They do not intend to become pregnant during the study period and, ?They are using highly effective birth control measures. |
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E.4 | Principal exclusion criteria |
1. History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis). 2. History of or current ocular infection or ocular inflammation within the past 3 months in either eye. 3. History of intraocular surgical procedure. 4. History of a current clinically relevant progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. 5. History of ocular laser surgery as determined by subject history and/or examination. 6. Therapy with an investigational agent within 30 days prior to the Screening Visit. 7. 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. 8. Additionally, the Alcon Medical Monitor may declare any subject ineligible for a valid medical reason. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary: Assessment of the pigmentation of trabecular meshwork. 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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 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 | Yes |
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 |
Non prostaglandin analogue use. |
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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.8.5 | 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 | 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
| |
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 | 1 |
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 |