E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ocular hypertension and glaucoma. |
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E.1.1.1 | Medical condition in easily understood language |
Ocular hypertension and glaucoma. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | Ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018304 |
E.1.2 | Term | Glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 is to compare the difference in mean Intraocular pressure values between the 2 groups at 6 months. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives includes a comparison of change of Intraocular pressure, IOP, from baseline between the treatment groups at month 3 and month 6, a comparison of mean IOP at month 3, a comparison of the result at each timepoint at month 3 and 6, as well as a comparison of tolerability and adverse events. A comparison of change from screening visit IOP after repeated dose administration of BUDPF or the LUDPF at month 3 and month 6 will also be performed. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- A patient suffering from ocular hypertension, XFG or POAG that has been on a preserved prostaglandin monotherapy for at least 6 weeks and needs treatment in both eyes
- At pre-screening and screening visit (09:00 ± 1 hr) the IOP is less than or equal to 21 mm Hg in both eyes.
- Patient is older than 39 years and younger than 85 years
- Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form |
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E.4 | Principal exclusion criteria |
- Unwilling to sign informed consent;
- Not at least 40 years old;
- Ocular condition that are of safety concern and that can interfere with the study results;
- Visual field defects with an MD value above -12dB with Humphey or above +12dB with Octopus on either eye;
- Contact lens wearer;
- Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy;
- Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye;
- Glaucoma surgery within the past 6 months on either eye;
- Ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye;
- Patients with pigmentary glaucoma on either eye;
- Patients with Neovascular glaucoma on either eye;
- Concomitant topical ocular medication that can interfere with study medication on either eye;
- Known hypersensitivity to any component of the trial drug solutions;
- Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement;
- Refractive surgery patients at any time;
- Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing;
- Inability to adhere to treatment/visit plan;
- Have participated in any other clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be the difference in mean IOP values between the 2 groups at 6 months |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- the difference in IOP values between the groups in change from baseline IOP at month 3 and month 6 respectively;
- the difference in IOP values between the groups in change from screening visit IOP, at month 3 and month 6 respectively;
- the difference in mean IOP between the 2 groups at 3 months;
- the difference in IOP between the 2 groups at each timepoints at months 3 and 6;
- safety endpoints includes visual acuity, adverse events, slit lamp biomicroscopy, ocular tolerability and optic nerve assessment;
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- the difference in IOP values between the groups in change from baseline IOP at month 3 and month 6;
- the difference in IOP values between the groups in change from screening visit IOP, at month 3 and month 6;
- the difference in mean IOP between the 2 groups at 3 months;
- the difference in IOP between the 2 groups at each timepoints at months 3 and 6; |
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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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 | No |
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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The end of trial is the last visit of the last subject. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |