E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Glaucoma, elevated intraocular pressure |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
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 |
To evaluate the steady-state plasma concentrations of Travoprost
free acid (AL-5848) following once daily administration of
Travoprost Ophthalmic Solution, 0.004% (preserved with
POLYQUAD) in pediatric patients with glaucoma or ocular
hypertension. To assess the safety of Travoprost Ophthalmic
Solution, 0.004% in pediatric patients with glaucoma or ocular
hypertension. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients < 18 years of age at the time of screening.
2. Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
NOTE: Patients with conditions requiring chronic treatment
with glucocorticoids resulting in steroid induced glaucoma may
be enrolled.
3. A parent/legal guardian (if necessary, a legally authorized
representative) must provide informed consent that has been
approved by the Institutional Review Board/ Independent Ethics
Committee (IRB/IEC), and children must agree to sign an
approved assent form when applicable.
4. Must agree to comply with the requirements of the study and
must be accompanied by a parent/guardian.
5. Aphakic patients with contact lenses may be enrolled. |
|
E.4 | Principal exclusion criteria |
1. Females of childbearing potential are excluded from
participation in the study, if they meet any of the conditions outlined in the protocol.
2. Patients with only 1 sighted eye or monocular patients
(including patients who cannot be dosed in both eyes for
any reason).
3. History of chronic, recurrent or severe inflammatory eye
disease (ie, scleritis, uveitis, herpes keratitis).
4. Ocular trauma requiring medical attention within the past
3 months prior to the Screening Visit.
5. Ocular infection or ocular inflammation within the past 30
days prior to the Screening Visit.
6. Clinically significant or progressive retinal disease such as
retinal degeneration, diabetic retinopathy, or retinal
detachment.
7. Other severe ocular pathology (including severe dry eye),
that in the opinion of the Investigator, would preclude the
administration of a topical prostaglandin analogue.
8. Intraocular surgery within the past 30 days prior to the
Screening Visit.
9. Any abnormality preventing reliable tonometry including
history of penetrating keratoplasty.
10. Any other conditions including severe illness which would
make the patient, in the opinion of the Investigator,
unsuitable for the study.
11. Hypersensitivity to prostaglandin analogues or to any
component of the study medications in the opinion of the
Investigator.
12. Less than 30 days before the Screening Visit of stable
dosing regimen of any medications (excluding the IOPlowering
treatments) or substances administered by any
route and used on a chronic basis. The dosing regimen of
these medications should not change during the study.
13. Therapy with another investigational agent or device within
30 days prior to the Screening Visit.
14. Concurrent use of topical prostaglandin analogues during
investigational product treatment period.
15. Children less than 5kg of body weight. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety:
• Extent of exposure
• Adverse events
• Best-corrected Visual Acuity (BCVA)
• Slit-lamp examination (eyelids/conjunctiva, cornea, lens, and
iris/anterior chamber including aqueous flare and inflammatory
cells)
• Dilated fundus parameters (vitreous, retina, macula, choroid, optic
nerve and cup/disc ratio)
• Ocular Hyperemia
• Alertness
• Vitals signs (pulse, blood pressure, respiration rate and body
temperature)
• 12 lead ECG
Pharmacokinetic:
• Cmax
• Tmax
• Tlast (for each patient with at least 1 quantifiable time point)
• AUC0-last (provided sufficient quantifiable data exist)
• AUC 0-∞ (provided sufficient quantifiable data exist)
• t1/2 (provided sufficient quantifiable data exist) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 7: pre-dose (trough) 0 min, 0.17 hr (10 min), 0.33 hr (20 min), 0.67 hr (40 min), and 1.33 hr (80 min) |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
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) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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) | No |
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
| No |
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 |
Brazil |
Colombia |
France |
Germany |
India |
Philippines |
Poland |
Portugal |
Saudi Arabia |
Singapore |
Spain |
Taiwan |
United Kingdom |
United States |
|
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
|
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |