E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ocular hypertension or open angle glaucoma patients are enrolled into this trial. |
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MedDRA Classification |
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 objective of this study is to investigate whether changes in ocular signs, symptoms and conjunctival inflammatory markers occur when patients are switched from latanoprost 0.005% eye drops with preservative to tafluprost 0.0015% eye drops without preservative. |
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E.2.2 | Secondary objectives of the trial | |
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:
1. Aged 18 years or more 2. A diagnosis of ocular hypertension or open-angle glaucoma in one or both eyes, for which the patient has been regularly using latanoprost 0.005% (Xalatan®) for at least six months before Screening (confirmed in anamnesis). 3. In the Screening visit evaluation, the presence of: o At least two ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade ≥ 2) upon non-instillation and considered for the two eyes together OR o One ocular symptom of at least mild severity (grade ≥ 2) upon non-instillation AND at least one of the following ocular signs in either eye with prior treatment: • Fluorescein tear break-up time (fBUT): less than 10 seconds • Corneal and conjunctival fluorescein staining: Corneal fluorescein staining score of at least grade I AND/OR Combined nasal and temporal staining scores of at least grade II • Blepharitis of at least mild severity (grade ≥ 1) • Conjunctival redness/hyperemia of at least mild severity (grade 1) • Tear production 10 mm or less on Schirmer test
4. A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes 5. Are willing to follow instructions 6. Have provided a written informed consent
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E.4 | Principal exclusion criteria |
1. Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception1 2. Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy 3. Any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery 4. IOP greater than 22 mmHg at 15:00 IOP measurement in either eye at Screening/Baseline visit 5. Use of preserved artificial tears at screening or within two weeks prior to screening visit
6. Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular glaucoma in either eye 7. Suspected contraindication to tafluprost therapy (hypersensitivity to tafluprost or any of the excipients). 8. Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening in eye(s) to be treated with study medication 9. Use of contact lenses at Screening or during the study 10. Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses, known risk factors for cystoid macular oedema or iritis/uveitis), systemic or psychiatric disease/condition (e.g. uncontrolled arterial hypertension, diabetes) that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient’s participation in the study as judged by the investigator 11. Current alcohol or drug abuse 12. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days 1 A reliable method of contraception is defined as sterilization or those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
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E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
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
| Information not present in EudraCT |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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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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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |