E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ocular hypertension and PAOAG, capsular glaucoma and pigmentary glaucoma. |
|
E.1.1.1 | Medical condition in easily understood language |
Ocular hypertension and glaucoma. |
|
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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035015 |
E.1.2 | Term | Pigmentary glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036719 |
E.1.2 | Term | Primary open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037118 |
E.1.2 | Term | Pseudoexfoliation glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
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 compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% eye drops to those of tafluprost 0.0015% and timolol 0.5% eye drops given as individual monotherapies.
The primary objectives of the study are to demonstrate that after a 3-month treatment period the IOP-lowering effect of preservative-free
fixed dose combination of tafluprost 0.0015% and timolol 0.5% eye
drops is superior to
o tafluprost 0.0015% eye drops in patients with open-angle glaucoma or ocular hypertension insufficiently controlled by tafluprost alone
o timolol 0.5% eye drops in patients with open-angle glaucoma or
ocular hypertension insufficiently controlled by timolol alone. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Aged 18 years or more
2. A diagnosis of ocular hypertension or open-angle glaucoma (either
POAG, capsular glaucoma or pigmentary glaucoma) in one or both eyes,
for which the patient has been regularly using prostaglandin (e.g.
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Xalatan®, Lumigan®, Travatan®, Taflotan®) or timolol 0.5% (several
brand names) monotherapy for at least two weeks before Screening
(confirmed in anamnesis).
3. Clinical need for additional IOP lowering medication as judged by the
investigator and at the Screening visit evaluation in either treated eye:
o IOP measurement of ≥ 22 mmHg at any time of the day for prior
timolol users (stratum 1)
OR
o IOP measurement of ≥ 20 mmHg at any time of the day for prior
prostaglandin users (stratum 2)
4. At the End-of-run-in visit after 2-week treatment with preservativefree
timolol 0.5% (stratum 1) or with preservative-free tafluprost
0.0015% (stratum 2) in either treated eye:
o IOP measurement of ≥ 22 mmHg at 8:00 for prior timolol users
(stratum 1)
OR
o IOP measurement of ≥ 20 mmHg at 8:00 for prior prostaglandin users
(stratum 2)
5. At the Baseline visit after a washout period of at least 4 weeks in
either eye:
o An increase of at least 2 mmHg in the average diurnal IOP (measured
at 8:00, 10:00, 16:00 and 20:00) as compared to the average diurnal IOP
at the End-of-run-in visit
6. A best corrected ETDRS visual acuity score of +0.6 logMAR or better
in both eyes (i.e. monocular patients are not eligible)
7. Are willing to follow instructions
8. Have provided a written informed consent |
|
E.4 | Principal exclusion criteria |
1. Females who are pregnant, nursing or planning pregnancy, or
females of childbearing potential who are not using a reliable method of
contraception
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 in the treated eyes, including prior refractive eye
surgery
4. IOP of 35 mmHg or greater at any time point in either eye at
Screening or End-of-run-in visits
5. Diagnosis of angle-closure glaucoma or secondary glaucoma other
than capsular or pigmentary glaucoma in either eye
6. Suspected contraindication to tafluprost or timolol therapy;
a. hypersensitivity to tafluprost/timolol or any of the excipients
b. low heart rate of <50 bpm (at Screening visit) or clinically relevant
low blood pressure for age, chronic obstructive pulmonary disease,
bronchial asthma, strong tendency to bronchospasm, certain cardiac
arrhythmias, the most common of which are second or third degree AV
block and bradycardia, or uncontrolled congestive heart failure
c. also for washout medication Azopt® (use of which is judged by the
investigator): hypersensitivity to brinzolamide or any of the excipients,
known hypersensitivity to sulphonamide, severe renal insufficiency or
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hyperchloraemic acidosis
7. 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
8. Use of contact lenses at Screening or during the study
9. Advanced visual field defect in either eye or anticipated progression
during the study as judged by the investigator
10. Inability to safely discontinue the use of ocular hypotensive
medications during the washout period
11. 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
12. Change of an existing chronic therapy that could substantially affect
the IOP or the study outcomes within 30 days prior to Visit 1, or
anticipated change in such therapy during the study
13. Current alcohol or drug abuse
14. Current participation in another clinical trial involving an
investigational drug/device, or participation in such a trial within the
last 30 days |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Variable:
o Change from baseline in the average diurnal IOP at 3 months |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Proportion of responders (e.g. a decrease of IOP of 20% or more or an IOP level of 16 mmHg or less) at 3 months
2) Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months
3) Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00) at 2 weeks, 6 weeks, 3 months and 6 months |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 3 months
2) 2 weeks, 6 weeks and 6 months
3) 2 weeks, 6 weeks, 3 months and 6 months |
|
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 65 |
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 |
Israel |
Russian Federation |
|
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
|
LSLV - Last Patient Last Visit |
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |