Travoprost 0.004% in Pediatric Glaucoma Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 130

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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.;Secondary Objective: Not Applicable;Primary end point(s): Primary Efficacy<br>? IOP change from baseline at Month 3<br>Secondary Efficacy<br>? Not applicable<br>Supportive Efficacy<br>? IOP change from baseline at Week 2 and Week 6<br>? IOP and IOP percent change from baseline at each visit (Week 2, Week 6, and Month 3)<br>? Percentage of patients who achieve at least a 15% reduction at each visit (Week 2, Week 6, and Month 3)<br>? Percentage of patients who reach an IOP within a normal range;Timepoint(s) of evaluation of this end point: Week 2, Week 6 and Month 3

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable

Related Trials

A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

WithdrawnPhase 3

Alcon Laboratories

Updated 4/29/2024