E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients suffering from unilateral or bilateral ocular hypertension or POAG, IOP controlled with beta-blocker monotherapy (IOP < 21 mmHg and visual field stable) |
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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 | 10030043 |
E.1.2 | Term | Ocular hypertension |
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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 | 10036719 |
E.1.2 | Term | Primary 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 |
Primary objective: To evaluate the subjective tolerance upon instillation (rate of patients experiencing symptoms of discomfort ) of carteolol LA compared to timolol LA in patients with simple ocular hypertension or POAG (superiority design) |
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E.2.2 | Secondary objectives of the trial |
• Assessment of each of the symptoms of the Glaucoma Symptom Scale [15] (Yes/ No): burning/smarting/stinging, tearing, dryness, itching, soreness/tiredness, feeling of something in the eye, blurry/dim vision, hard to see in daylight, hard to see in dark places and halos around the light (for those who report a given symptom, a bothersome scale will be used: very, somewhat, a little, not at all) • Subjective tolerance upon isntillation graded as very good/good/bad/very bad • External and Slit lamp examination • Break up time • Fluorescein test • Lissamine green test. • IOP measured at 12 PM (+/- 30mn) • Visual acuity • Visual field • Fundoscopy • Adverse events • Compliance
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult patients, men or women • Suffering from unilateral or bilateral ocular hypertension or POAG • IOP controlled with beta-blocker monotherapy (IOP < 21mmHg and visual field stable) • written informed consent |
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E.4 | Principal exclusion criteria |
• Age < 18 years • IOP not controlled with beta-blocker monotherapy • Angle closure, congenital and secondary glaucoma • Any pathology contraindicating an IOP measurement • Any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months • Previous intolerance to carteolol or timolol, or to any other ingredients of the tested products • Beta-blocker contraindications • Ocular corticosteroids • Contact lens wearers • Severe systemic or ocular disease • Hypotension • Drug, alcohol abuse • Involvement in the last 30 days in any other investigational drug study • Expected change in treatment of concomitant disease • Patients with a history of recurrent ocular herpes and/or recurrent uveitis. • Change in ocular treatment within the last month. • Patients treated with other topical ocular treatment within the last month • Pregnant or lactating women. • Women of child-bearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy. • Patients for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study. • Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow up in the study period. • Patients with neurotic, psychiatric disorders or suicidal tendencies
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety : Primary variable : • Rate of patients experiencing discomfort upon instillation after 3 months of treatment
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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 | Yes |
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 |
single-masked (investigator) with patient masked to the treatment name |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |