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.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IOP change from baseline at Month 3
Secondary outcome
Not Applicable
Background summary
Glaucoma is an eye condition associated with an abnormally high pressure in the
eye (called intraocular pressure or IOP). If left untreated, elevated IOP may
eventually cause damage to the optic nerve and a loss of vision. Treatment for
glaucoma is aimed at lowering pressure in the eye and there are different types
of medications that can be used for this; Among the pharmacological treatments,
the most commonly used are eye drops containing drugs of different classes.
Studies describing off-label use of Travoprost Solution, 0.004% (preserved with
BAK) or latanoprost 0.005% in pediatric glaucoma populations suggest that
prostaglandin analogs generally confer significant IOP-lowering efficacy, are
well tolerated with few systemic side effects, and provide a long duration of
action with convenience through once daily administration (Yanovitch 2009,
Helmanova 2007). These studies suggest that statistically significant and
clinically meaningful IOP reductions in pediatric populations were observed
when Travoprost was used either as a monotherapy or adjunctive to other topical
ocular hypotensive medications. Ocular side effects associated with Travoprost
or the prostaglandin analogue class such as conjunctival injection and ocular
irritation were generally mild and transient. No evidence of iris pigmentation
changes was noted and no clinically relevant systemic side effects were
reported. Therefore, Travoprost Ophthalmic Solution, 0.004% preserved with
POLYQUAD is the most appropriate formulation to evaluate in the pediatric
glaucoma population.
Study objective
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.
Study design
Approximately 4 months during, multicenter, double-masked, randomized study
with a parallel-group.
Patients will be randomized in a 1:1 manner to receive treatment with
Travoprost Ophthalmic Solution, 0.004% or Timolol Ophthalmic Solution, 0.5% (or
0.25% for children < 3 years of age), respectively.
Intervention
Not applicable
Study burden and risks
In a period of 4 months, patients need to come to the hospital 5 times for an
ophthalmic examination. Each visit will take approximately 1 to 2 hours of
their time. None of the tests are experimental.
Participation in this trial may cause little risk/ discomfort:
If the child is currently using medication to control the pressure in his/her
eyes, an increase in the pressure could occur during this study. This may
occur at any time during the study and particularly when they stop the drops
they are taking before beginning the study (washout period). An increase in the
pressure in the eye can result in damage to the optic nerve and consequently
cause loss of vision and, depending on the severity and duration of the high
pressure, may result in blindness. If the pressure in the child*s eyes
increases, the child*s study doctor will determine whether they should continue
in the study or be removed from the study. In addition, the study doctor will
discuss alternative therapies for the child.
The tests used in the examinations should cause little discomfort. The
eye-pressure test involves the placement of eye drops containing a small amount
of a numbing drop into the eye.
It is important that the child not rub his/her eyes for at least 15 minutes
after the drops are put in the eye since small particles or dust in the eye
might scratch the cornea and the numbing drop would make the child temporarily
unable to feel the pain. Minor scratching of the corneal surface may rarely
occur when the pressure in the eye is measured and usually heals very quickly.
The eye drops put into the child*s eye to dilate (enlarge) the pupil to allow
for a better view of the inside and back of the eye may cause his/her vision to
be blurred for a few hours and may also cause the child to be more sensitive to
bright light until the medication wears off. While your child*s eyes are
dilated, they should be protected from bright light. Wearing sunglasses for
several hours after dilation can help reduce the discomfort of light
sensitivity.
Both of the medications tested in this study can cause side effects.
Travoprost is currently marketed (TRAVATAN®) to reduce pressure in the eyes of
adult patients with open-angle glaucoma or ocular hypertension. A common side
effect reported with the use of Travoprost has been color changes in the iris
(eye color) causing blue eyes to turn brown. Also color changes in the eyelids
have been reported as well as increased eye lash length, thickness, color
and/or number of lashes. These changes may be permanent. In other Travoprost
clinical studies, the most common side effect observed was red eyes (hyperemia)
in 30-50 percent of the subjects. Other events reported in 5-10 percent of the
subjects were a decrease in vision, eye discomfort, a feeling of something in
the eye or itchy eyes (pruritus).
Side effects reported with the use of timolol eye drops include dizziness,
decreased heart rate, decreased blood pressure, and shortness of breath.
Allergic reactions to the study eye drops are usually local (affecting the eye
with itching, redness, etc.) rather than generalized (throughout the body).
Allergic reactions can make the eye itch and cause eye redness.
Due to the nature of this research study and the unknown side effects of the
study drug on pregnant women, fetuses, unborn children, and nursing infants,
your child is not permitted to participate in this study if she is pregnant, at
risk of becoming pregnant, or a nursing mother. If your child is a female able
to bear children she must have a negative urine pregnancy test before
participating in the study and she must agree to use an a highly effective form
of contraception during the course of this study if she is sexually active.
Adequate birth control methods include: (A) true abstinence; (B) hormonal
methods: implantable chemical contraceptives; or (C) mechanical methods:
intrauterine device (IUD) with progestogen; or (D) surgical sterilization of
partner. The child must also agree to avoid becoming pregnant during the
course of the study, and must immediately stop taking the study drops and
inform your study doctor should she become pregnant.
If the child is a male whose partner is of childbearing potential, he should
make sure that a partner uses a reliable means of birth control (such as IUD
with progestogen to avoid fathering a child while taking part in this study.
This is because the effects of the study drug on the development of an unborn
child are not known.
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Listed location countries
Age
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.
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, * 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.
17. Patients with reactive airway disease including bronchial
asthma or a history of bronchial asthma, severe chronic
obstructive pulmonary disease; sinus bradycardia; sick sinus
syndrome, sino-atrial block, second or third degree
atrioventricular block not controlled with pace-maker; overt
cardiac failure; and cardiogenic shock.
18. Patients with severe allergic rhinitis.
19. Patients with corneal dystrophies.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-001324-34-NL |
| ClinicalTrials.gov | NCT01652664 |
| CCMO | NL43025.078.13 |