EUCTR2011-004587-29-DE进行中（未招募）不适用
A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients with Open-Angle Glaucoma or Ocular Hypertension - A Multicenter, Double-Masked Study of the Safety and Efficacy of 30 µg/mL Travoprost
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 720
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
- •?Inclusion Criteria:
- •1. Patients 18 years of age or older
- •2. Diagnosis of open-angle glaucoma (including open-angle
- •glaucoma with pseudoexfoliation or pigment dispersion)
- •or ocular hypertension.
- •3. Qualifying mean IOP (after washout) at both the
- •Eligibility 1 and 2 Visits in at least 1 eye (the same eye)
- •= 24 mmHg at the 8 AM (± 30 minutes) time point
- •= 21 mmHg at the 10 AM (± 30 minutes) and 4 PM
- •(± 30 minutes) time points.
- •Mean IOP must be = 36 mmHg at all time points, OU.
- •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.
- •4. Must be able to understand and sign an informed consent
- •form that has been approved by an Institutional Review
- •Board/Independent Ethics Committee.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
排除标准
- •?1. Women of childbearing potential (ie, those who are not postmenopausal for at least 1 year or surgically sterile) are ?excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy
- •throughout the study.
- •?Related to disease/condition being investigated (either eye)
- •2. Modified Shaffer angle grade < 2 as measured by
- •gonioscopy (extreme narrow angle with complete or
- •partial closure).
- •3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
- •vertical measurement).
- •4. Severe central visual field loss defined as a sensitivity
- •= 10 dB in at least 2 of the 4 visual field test points closest
- •to the point of fixation.
- •5. Patients who in the opinion of the Investigator cannot
- •discontinue all IOP-lowering ocular medication(s) per the
- •appropriate washout schedule prior to the E1 Visit.
- •Excluded from participation if they are currently pregnant,
- •have a positive result on the urine pregnancy test at
- •Screening, or intend to become pregnant during the study
- •period; are breast-feeding; or are not in agreement to use
- •adequate birth control methods to prevent pregnancy
- •throughout the study.
- •Related to disease/condition being investigated (either eye)
- •2. Modified Shaffer angle grade < 2 as measured by
- •gonioscopy (extreme narrow angle with complete or
- •partial closure).
- •3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
- •vertical measurement).
- •4. Severe central visual field loss defined as a sensitivity
- •= 10 dB in at least 2 of the 4 visual field test points closest
- •to the point of fixation.
- •5. Patients who in the opinion of the Investigator cannot
- •discontinue all IOP-lowering ocular medication(s) per the
- •appropriate washout schedule prior to the E1 Visit.
- •Related to previous or current ocular disease/condition
- •(either eye)
- •6. History of chronic, recurrent or severe inflammatory eye
- •disease (ie, scleritis, uveitis, herpes keratitis).
- •7. Ocular trauma requiring medical attention within the past
- •6 months prior to the Screening Visit.
- •8. Ocular infection or ocular inflammation within the past
- •3 months prior to the Screening Visit.
- •9. Clinically significant or progressive retinal disease such as
- •retinal degeneration, diabetic retinopathy, or retinal
- •detachment.
- •10. Best-corrected visual acuity (BCVA) score worse than
- •55 ETDRS letters (equivalent to approximately 0.60
- •logMAR, 20/80 Snellen, or 0.25 decimal).
- •11. Other severe ocular pathology (including severe dry eye),
- •in the opinion of the Investigator, that would preclude the
- •administration of a topical prostaglandin analog.
- •12. Intraocular surgery within the past 6 months prior to the
- 另有 4 项未显示
研究者
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