EUCTR2009-013178-42-BE进行中（未招募）不适用
A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APSDosed Once Daily in Patients with Open-Angle Glaucoma or Ocular Hypertension - Safety Study of DuoTrav APS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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 of either sex and any race, 18 years of age or older.
- •2. Patients diagnosed with open-angle glaucoma (with or without pseudoexfoliation or
- •pigment dispersion component) or confirmed ocular hypertension who would benefit
- •from a fixed combination medication, in the opinion of the Investigator.
- •NOTE: Patients are eligible if they are insufficiently responsive to an intraocular
- •pressure lowering monotherapy, as documented in the patients' medical records.
- •NOTE: Patients may currently be treated with unfixed or fixed combination IOPlowering
- •medications. Patients may be eligible if they are insufficiently responsive or
- •intolerant to a combination therapy (fixed or unfixed), excluding combination therapies
- •containing a prostaglandin analogue and a beta-blocker. Patients may be eligible if
- •they are well controlled on a combination therapy (fixed or unfixed) containing a
- •prostaglandin analogue and a beta-blocker.
- •3. Patients currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering
- •medication.
- •4. Only patients who satisfy all Informed Consent requirements may be included in the
- •study. Section 18.4. lists the required elements of the Informed Consent, the origins of
- •which are derived from the Declaration of Helsinki, amended in 2002 (see Section
- •18.3.). The Informed Consent documents must be executed as follows: the patient must
- •read, sign, and date the Informed Consent document before any study-related
- •procedures are performed. The person who conducted the informed consent discussion
- •must also sign and date the Informed Consent document.
- •Only patients who are able to read, sign, and date the informed consent can be enrolled.
- •The Informed Consent form signed by patients must have been approved by the
- •IRB/IEC for the current study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •Patients demonstrating any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article, safe participation in this study, or affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude patients from enrollment in this study:
- •1. Females of childbearing potential (those who are not surgically sterilized or at least two years post-menopausal) are excluded from participation in the study if they meet any one of the following conditions:
- •They are currently pregnant or,
- •They have a positive result on the urine pregnancy test at the Screen/Enrollment
- •Visit or, they intend to become pregnant during the study period or,
- •They are breast-feeding or, they are not using highly effective birth control
- •o Hormonal – oral, implanted, topical, or injected contraceptives;
- •o Mechanical – spermicide in conjunction with a barrier such as a condom or
- •diaphragm or; IUD
- •Exclusion Criteria related to the disease condition being investigated (open-angle
- •glaucoma or ocular hypertension):
- •2. Patients with any form of glaucoma other than open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or confirmed ocular
- •hypertension.
- •3. Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with
- •complete or partial closure) in either eye, as measured by gonioscopy (see
- •Section 18.1.3.).
- •4. Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
- •5. Patients with severe central visual field loss in either eye (see Section 9.4.6. for
- •Exclusion Criteria related to ocular/systemic patient history or current ocular condition in either eye:
- •6. History of (i.e., within the last 3 months), or current chronic, recurrent, or severe ocular nfection, inflammation or inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study in the opinion of the Investigator.
- •7. History of ocular trauma within the past 6 months.
- •8. Intraocular laser surgery within the past 6 months.
- •9. Ocular laser surgery within the past 3 months.
- •10. Best-corrected visual acuity score worse than 55 ETDRS letters (equivalent to
- •approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal). See Section 9.4.9. for
- •details on the procedure.
- •11. History of, or current clinically relevant (in the opinion of the Investigator) or
- •progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- •12. Any abnormality preventing reliable applanation tonometry.
- •13. History of or current bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-adrenergic blocking agent.
- •14. History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease (e.g., sinus bradycardia, overt cardiac failure, greater than first degree
- •atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled
- •hypertension) that would preclude the safe administration of a topical beta-adrenergic blocking agent.
- •15. History of spontaneous or current hypoglycemia or uncontrolled diabetes.
- •16. History of or current severe allergic rhinitis and bronchial hyper reactivity.
- •17. History of or current corneal dystrophies.
研究者
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