| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Pediatric glaucoma;elevated intraocular pressure |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| 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 |
| The primary objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) is noninferior to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric glaucoma patients. |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Patients 2 months to <18 years of age
2. Diagnosis of pediatric glaucoma
3. Patients with conditions requiring chronic treatment with glucocorticoids resulting in steroid induced glaucoma may be enrolled as long as the patient has been on a stable dose of steroids for at least 30 days prior to the Screening Visit.
4. Qualifying mean IOP at the Eligibility Visit in at least one eye must be:
• ≥ 20 mmHg at the 9 AM (± 60 minutes) time point
Note: Mean IOP is the average of 2 successive IOP measurements in the same eye, as described in the Manual of Procedures. A third measurement is required if the first 2 measurements differ by more than 4 mmHg.
5. Aphakic patients with contact lenses may be enrolled. If study drops are to be instilled with lens in place, patient will be
provided with a contact lens to be used during the study.
6. Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized
representative prior to any procedure specified in the protocol, including screening procedures. |
|
| E.4 | Principal exclusion criteria |
1. Females of childbearing potential are excluded from participation in the study if they meet any of the following conditions:
a. They are currently pregnant
b. They have a positive result on a pregnancy test at the Screening Visit
c. They intend to become pregnant during the study period
d. They are breast feeding
e. They are not using any of the following highly effective birth control measures:
• True abstinence – when this is in line with the preferred and usual lifestyle of the subject. If subjects become sexually active, they must agree to use one of the birth control methods (hormonal, mechanical, or
surgical) listed below for the remainder of the study.
• Hormonal – implanted contraceptives.
• Mechanical –IUD with progestogen.
• Surgical – vasectomized partner (must be ≥ 6 months post vasectomy).
Note: All females of childbearing potential must consent to a urine pregnancy test at the Screening Visit and upon exiting the study.
Note: Females of childbearing potential will be instructed to immediately inform the Investigator if they become pregnant during the study. Should this occur, the
Investigator shall immediately contact the Sponsor).
2. Patients who have previously failed long-term treatment with a prostaglandin analog or timolol to control IOP or patients in
which reasonable IOP control would not be expected from pharmacological treatment.
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 in the study eye.
7. Severe ocular pathology (including severe dry eye) in the opinion of the Investigator that would preclude the
administration of a topical prostaglandin analog or a topical beta-blocker.
8. Intraocular surgery within the past 30 days in the study eye prior to the Screening Visit.
9. Any abnormality preventing reliable applanation tonometry, including a history of penetrating keratoplasty.
10. Patients with a history of previous cyclodestructive procedure.
11. Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable
for the study.
12. Hypersensitivity to any component of the study medications, including medications administered during study exams, in the opinion of the Investigator.
13. History of congenital cardiovascular anomalies or abnormalities which would preclude the safe administration of
a topical beta-blocker. In the event that the effects of the study medications are unclear, the patient may participate with
written approval from the patient’s cardiologist.
There is a potential for additive effects resulting in hypotension and/or marked bradycardia when eye drops with
timolol are administered concomitantly with oral calcium channel blockers, quanethidine or beta-blocking agents, antiarrhythmics,
digitalis glycosides or parasympathomimetics.
The hypertensive reaction to sudden withdrawal of clonidine or can be potentiated when taking beta-blockers. Potentates systemic beta-blockade (e.g. decreased heart rate) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, cimetidine) and timolol. Beta-blockers may increase the hypoglycemic effect of anti-diabetic agents.
Beta-blockers can mask the signs and symptoms of hypoglycemia.
Investigators must use their clinical judgment regarding the use of these products during the study.
14. Use of any additional topical or systemic ocular hypotensive medication during the study.
15. Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering
treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents). The dosing regimen of these medications should not change during the study.
16. Therapy with another investigational agent or device within 30 days prior to the Screening Visit. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Efficacy
• IOP change from baseline at Month 3
Secondary Efficacy
• Not applicable
Supportive Efficacy
• IOP change from baseline at Week 2 and Week 6
• IOP and IOP percent change from baseline at each visit (Week 2, Week 6, and Month 3)
• Percentage of patients who achieve at least a 15% reduction at each visit (Week 2, Week 6, and Month 3)
• Percentage of patients who reach an IOP within a normal range |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Week 2, Week 6 and Month 3 |
|
| 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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | 2 |
| 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 | 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 |
| Belgium |
| Brazil |
| Colombia |
| France |
| Germany |
| India |
| Mexico |
| Peru |
| Philippines |
| Poland |
| Portugal |
| Romania |
| Russian Federation |
| Saudi Arabia |
| Singapore |
| Spain |
| Taiwan |
| Ukraine |
| 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 | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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