EUCTR2012-001324-34-NL进行中（未招募）1 期
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 - Travoprost 0.004% in Pediatric Glaucoma Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •= 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
排除标准
- •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
- •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.
- 另有 18 项未显示
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