EUCTR2005-004201-29-HU进行中（未招募）不适用
THE EFFICACY AND SAFETY OF TIMOLOL MALEATE 0.5% COMPARED TO BRINZOLAMIDE 1% EACH GIVEN TWICE DAILY WHEN ADDED TO TRAVOPROST 0.004% GIVEN EACH EVENING IN PRIMARY OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSIVE PATIENTS
Alcon Hungarian ltd0 个研究点目标入组 170 人开始时间: 2006年1月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
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
- •18 years of age or older
- •willingness to comply with the investigator's and protocol's instructions
- •patient's signature on the Institutional Review Board approved informed consent document (each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form).
- •have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
- •the intraocular pressure must be considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
- •in eyes not included in the study the intraocular pressure should be able to be controlled to a safe level on no pharmacologic therapy or study drug(s) only during the trial.
- •patients must have been treated with travoprost once daily as monotherapy for a minimum of 6 weeks at Visit 1 and have an intraocular pressure of between18 and 32 mm Hg inclusive in at least one eye and < 32 mm Hg in both eyes.
- •at baseline vsit the intraocular pressure should be between 18 and 32 mm Hg inclusive at the 08:00H measurement (Visit 2) in at least one eye and < 32 mm Hg at all time points in both eyes.
- •isual acuity should be 6/60 or better in both eyes.
- •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
- •presence of exfoliation syndrome or exfoliation glaucoma
- •any abnormality preventing reliable applanation tonometry in study eye(s)
- •any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in the study eye
- •any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- •any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
- •females of childbearing potential not using reliable means of birth control
- •pregnant or lactating females
- •any clinically significant, serious, or severe medical or psychiatric condition
- •participation (or current participation) in any investigational drug or device trial within the previous 30 days prior to the screening visit (Visit 1)
- •intraocular conventional surgery or laser surgery within the past three months in the study eye(s)
- •according to the investigator’s best judgment risk of visual field or visual acuity worsening as a consequence of participation in the trial
- •inability to understand the trial procedures, and thus inability to give informed consent
- •any anticipated change in systemic hypotensive therapy during the active treatment portion of the trial (Visits 1-4) which might include adjustments to oral ß-adrenergic blockers, ?-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers
- •progressive retinal or optic nerve disease from any cause
- •unwillingness to accept the risk of iris color or eyelash changes
- •a history of, or at risk for, uveitis or cystoid macular edema (CME) in this trial
- •history of ocular herpes simplex
- •contraindications to ?-blocker therapy including: reactive airway disease, secondary or third degree heart block, bradyarrhythmias, and uncontrolled heart failure
- •history of sulfa allergy
- •Fuch’s corneal dystrophy, moderate or severe guttata, or a subjectively low endothelial cell count by slit lamp biomicroscopy
研究者
相似试验
尚未招募
4 期
sefulness of Timolol in a condition of vascular overgrowth of tissueCTRI/2019/04/018581Indian Association of Dermatologists Venereologists and Leprologists Research grant
招募中
3 期
The efficacy and safety of 0.5% topical timolol on corneometry and transepidermal water loss after ablative fractional CO2 laser for atrophic acne scars: a split face randomized double blind placebo-controlled trialWe considered that timolol may have an effect in wound healing promotion in patients who undergo AFCO2 resurfacing. Our study aimed to investigate the efficacy and safety of 0.5% topical timolol maleaTCTR20190722005none25
已完成
2 期
Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)Infantile HemangiomaNCT02913612Kanecia Obie Zimmerman105
招募中
1 期
Efficacy and safety of 0.15% Thiamidol combination with hyaluronic acid versus 0.15%Thiamidol or hyaluronic acid alone in treatment of melasma : A randomized single-blind trialMelasma is acquired light to dark-brown poorly circumscribed maculees. It's mainly seen in premenopausal women. The etiology of melasma is the combination of genetic,hormonal and ultraviolet light exmelasmaTCTR20200710001Faculty of medicine, Thammasat university96
撤回
2 期
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)Infantile HemangiomasNCT01408056Children's Hospital of Philadelphia