E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glaucoma or ocular hypertension |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
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 | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018304 |
E.1.2 | Term | 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 |
To investigate the occurrence and severity of signs and symptoms of ocular surface disease in patients having ongoing chronic topical treatment for glaucoma or OH. |
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E.2.2 | Secondary objectives of the trial |
To correlate the findings to the type of treatment and exposure of the eye to BAC in the ophthalmic formulations used. To investigate the concordance between findings in made in ophthalmologist’s examination and symptoms reported by the patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of any race and either sex meeting all of the following criteria will be considered eligible for this study:
Glaucoma patients: 1. Aged 18 years or more 2. Diagnosis of glaucoma/OH: primary open angle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma, ocular hypertension (being treated) 3. Are willing to follow instructions 4. Have provided a written informed consent
Control patients (equal number of males and females at each center): 1. Aged 40 years or older 2. No prior or current use of ocular hypertensive medications 3. Willing to follow instructions 4. Have provided written informed consent
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E.4 | Principal exclusion criteria |
1. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days 2. Eye surgery performed within the last 6 months 3. Patients with known or seasonal allergy 4. Known alcoholism, or other drug abuse that could influence the variables to be studied
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E.5 End points |
E.5.1 | Primary end point(s) |
• Occurrence and severity of ocular signs and symptoms • Comparison of variables to control patient group • Relationship between use of BAC (in eye drops) and ocular signs and symptoms • Concordance between findings made by ophthalmologist and symptoms reported to a nurse by the patients
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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 | 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 | 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 |
No IMP in the control group (no prior or current use of ocular hypertensive medications). |
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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 | 30 |
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 study will end on the date that the last patient completes the telephone contact. |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | 0 |