A MULTICENTER, DOUBLE-MASKED, RANDOMIZED, PARALLEL ASSIGNMENT, STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION MANUFACTURED BY INNOPHARMA INC. WITH RESPECT TO AZOPTâ„¢ (BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION) IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 286
- 试验地点
- 6
- 主要终点
- To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azoptâ„¢ (Brinzolamide 1% ophthalmic suspension).
研究概览
简要总结
A multicenter, double-masked, randomized, parallel assignment, study to determine the therapeutic equivalence of generic Brinzolamide 1% ophthalmic suspension manufactured by InnoPharma Inc with respect to Azoptâ„¢ (Brinzolamide 1% ophthalmic suspension) in patients with primary open angle glaucoma or ocular hypertension
Phase III therapeutic equivalence trial
Male and female patients 18 years of age or older, diagnosed with open-angle glaucoma or ocular hypertension.
286 evaluable patients with primary open angle glaucoma or ocular hypertension with provision for approximate drop-out rate of 20 %.
Multiple centers each across US, India, Singapore, Malaysia and Srilanka are planned
Primary objective : xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
· To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azopt™ (Brinzolamide 1% ophthalmic suspension).
Secondary objective:
To evaluate the safety and efficacy of Brinzolamide 1% ophthalmic suspension in patients with primary open angle glaucoma or ocular hypertension
Primary Outcome Measures:
· Intraocular pressure (IOP) at baseline and at 4, 8 and 12 weeks after treatment.
Secondary Outcome Measures:
- Reduction in intraocular pressure (IOP) from baseline at the end of 4, 8 and 12 weeks of treatment.
- Occurrence of adverse events during the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension (including pigment dispersion syndrome). 2.If of child bearing potential.
- •â€¢Must use a reliable means of contraception for the duration of the study or surgically sterilized. •Must have a negative pregnancy test. •Must be non-lactating 3.9 am IOP measurements ≥ 24 ≤ 36 mmHg, inclusive, in at least one eye, at two eligibility visits separated by one week 4.The IOP criteria to be met by the same eye 5.Visual Acuity of 6/24 or better(or its equivalent by logMAR) in both eyes 6.Gonioscopy angle of ≥ 3 in both eyes 7.Patients with a level of understanding and willingness to fully comply with all visits and study procedures scheduled by the study site as evidenced by written informed consent.
排除标准
- •1.Patients with any form of glaucoma other than open-angle glaucoma 2.Patients with Schaffer angle grade 3 (overall, however occludable angles treated with patent iridectomy are allowed ) 3.Patients with a cup/disc ratio greater than 0.8 4.Patients with severe central visual field loss 5.Best corrected VA score worse than 20/200 Snellen (equivalent to +1.0 log Mar) 6.Chronic, recurrent or severe inflammatory eye disease (blepharitis or clinically non-significant conjunctival hyperaemia allowed) 7.Clinically significant or progressive retinal disease or optic nerve disease from any cause apart from glaucoma 8.Other ocular pathology especially Fuch’s endothelial dystrophy, moderate to severe guttata, subjectively low endothelial cell count by slit lamp biomicrscopy or any abnormality preventing reliable applanation tonometry 9.Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist like MAO inhibitors.
- •10.History of hypersensitivity to oral or topical CAIs, sulfonamide drugs or to any component of these medications or the study medications or ingredients 11.Contact lens use during the active treatment portion of the trial.
- •However if patient agrees to avoid use of contact lens use 15 minutes before and after drug administration, such patient can be included 12.Active ocular allergies.
- •13.Conventional ocular surgery or laser surgery within the 3 months prior to visit
- •14.Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- •15.Active ocular diseases or uncontrolled systemic disease.
- •Patients requiring concomitant aggressive therapy with antihypertensives or steroids or patients on oral CAIs like acetazolamide or methazolamide.
- •However patients on stable dose of antihypertensive therapy or stable doses of dermal or inhaled steroids can be allowed 16.Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control 17.Participation in any study during past 30 days 18.Relative or employee of the treating investigator.
结局指标
主要结局
To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azoptâ„¢ (Brinzolamide 1% ophthalmic suspension).
时间窗: To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azoptâ„¢ (Brinzolamide 1% ophthalmic suspension).
次要结局
- To evaluate the safety and efficacy of Brinzolamide 1% ophthalmic suspension in patients with primary open angle glaucoma or ocular hypertension(NA)