CTRI/2009/091/000528已完成3 期
A multi-center, double-masked study of the safety and efficacy of Travoprost APS compared to TRAVATAN in patients with open-angle glaucoma or ocular hypertension. - Travoprost in Open Angle Glaucoma and ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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. Diagnosis of ocular
- •hypertension in treatment-naïve patients should be documented as elevated IOP (i.e.,≥ 21 mmHg) at multiple points within the past year.
- •3. Patients not currently on any IOP-lowering medication or currently on a stable treatment (i.e., at least 30 days) with an IOP-lowering monotherapy (not a fixed combination
- •product) medication.
- •4. Patients must meet the following IOP entry criteria in at least one eye at Eligibility Visits 1 & 2:
- •? Mean IOP ≥ 24 mmHg at the 09:00 time point, and
- •? Mean IOP ≥ 21 mmHg at the 11:00 and 16:00 time points.
- •? The mean IOP in either eye at Screening or Eligibility must not be greater than 36 mmHg at any time point.
- •The mean IOP is the average of IOP measurements in the same eye, The same eye(s) must qualify at all qualifying time points.
- •5. Only patients who satisfy all Informed Consent requirements may be included in the study. the origins of
- •which are derived from the Declaration of Helsinki, amended in 2002. 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. The Informed Consent form signed by patients must have been approved by the IRB/IEC for the current study.
排除标准
- •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 Screening 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 measures:
- •o Hormonal ? oral, implanted, topical, or injected contraceptives;
- •o Mechanical ? spermicide in conjunction with a barrier such as a condom or diaphragm or; IUD
- •Note: All females of childbearing potential must consent to a urine pregnancy test upon entering and exiting the study.
- •Note: Females of childbearing potential will be instructed to immediately discontinue study medications and inform the Investigator if they become pregnant during the study. Should this occur, the Investigator shall exit the patient from the study and immediately contact the Sponsor.
- •Note: For non-sexually active females, abstinence may be regarded as an adequate
- •method of birth control; however if the patient becomes sexually active during the study, she must agree to use adequate birth control methods as defined above for the remainder of the study.
- •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.
- •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.
- •Exclusion Criteria related to ocular/systemic patient history or current ocular condition in
- •either eye:
- •6. History of, or current chronic, recurrent, or severe 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.
- •7. History of ocular trauma within the past 6 months.
- •8. Intraocular 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).
- •11. Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination.
- •12. History of, or current clinically relevant (in the opinion of the Investigator) or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinaldetachment.
- •13. Any abnormality preventing reliable applanation tonometry.
- •14. History of, or current evidence of severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- •15. History of severe or serious hypersensitivity to prostaglandin drugs or their analogues or to any components of the study medications.
- •16. Patients who are unwilling to remove their contact lenses prior to instillation of the study medication and to leave them out for a minimum of 15 minutes following instillation before reinserting the lenses for the duration of the study.
- •Exclusion Criteria related to systemic or ocular medications:
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