EUCTR2012-002078-30-SI进行中（未招募）不适用
Assessing the Efficacy and Tolerability of TRAVATAN® Solution without BAK, containing Polyquad® Preservative (travoprost 0.004%) versus LUMIGAN® 0.01% Solution with BAK (bimatoprost 0.01%) in Treatment Naïve patients with Ocular Hypertension or Open Angle Glaucoma
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
- 104
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.Must be at least 18 years of age.
- •2.Must be diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
- •3.Must have an IOP between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
- •4.Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- •5.Must have a baseline a tear film break up time (TBUT) of = 5 seconds.
- •6.Must have a baseline ocular staining grade of < III (i.e. between 0 and II) based on Oxford scale.
- •7.In case one eye is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
- •8.Must be able to follow instructions and be willing and able to attend all study visits.
- •9.Must have best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
- •10.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1.Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
- •2.Any abnormality preventing reliable applanation tonometry in either eye.
- •3.Corneal dystrophies in either eye.
- •4.Any opacity or patient uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
- •5.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- •6.History of severe dry eye, keratoconjunctivitis sicca, ocular pemphigoid or Stevens-Johnson syndrome.
- •7.Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
- •8.History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications)
- •9.Contact lens wearers are excluded
- •10.Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
- •11.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
- •12.Progressive retinal or optic nerve disease from any cause.
- •13.A history of, or at risk for uveitis or cystoid macular edema (CME).
- •14.Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
- •15.Women of childbearing potential not using reliable means of birth control. A reliable effective method of birth control must have been used for at least one month prior to Visit 1 and is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
- •16.Women who are pregnant or lactating
- •17.Unwillingness to risk the possibility of darkened iris or eyelash changes.
- •18.A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
- •19.Participation in any other investigational study within 30 days prior to the Screening Visit.
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