E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG); primary open-angle glaucoma [POAG] or capsular glaucoma. |
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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 | 10030856 |
E.1.2 | Term | 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 |
The objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost 0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve (12) months. |
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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 |
1. Have provided a written informed consent 2. Aged 18 years or more 3. A diagnosis of ocular hypertension or open-angle glaucoma (either POAG or capsular 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). 4. In the Screening visit evaluation, the presence of: • At least two ocular symptoms considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade ≥ 2) upon non-instillation OR • 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 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
5. A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes 6. Negave pregnancytest result at the screening visit, or, consistently and correctly used reliable method of contraception during the study 7. Are willing to follow instructions
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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 eye drops (other than latanoprost) including 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 capsule2 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome measures: a) Change from screening in corneal confocal microscopic findings at month 12 b) Change from screening in ocular symptoms upon non-instillation at month 12 c) Change from screening in ocular signs at month 12 Safety and QoL variables: d) Descriptive statistics, identification of change(s) from screening
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | 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.8.3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |