CTRI/2021/05/033515已完成3 期
A Therapeutic Equivalence Study Of Generic Brinzolamide 1% Ophthalmic Suspension Compared To Reference Listed Drug Azopt® (Brinzolamide) Ophthalmic Suspension 1% In Subjects With Primary Open Angle Glaucoma Or Ocular Hypertension
Sun Pharmaceutical Industries Ltd SPI0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Male or nonpregnant females aged 18 years or older with chronic open-angle glaucoma or ocular
- •hypertension in both eyes.
- •-Provide signed and dated informed consent in accordance with good clinical practice (GCP) and
- •local legislation prior to any study procedure.
- •-Be able and willing to follow study instructions and complete all required visits.
- •-Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive
- •medication(s) or switch ocular hypotensive medications and undergo an appropriate washout
- •-Adequate wash-out period prior to the baseline of any ocular hypotensive medication
排除标准
- •Subjects with angle closure glaucoma
- •- Females who are pregnant, breast feeding, or planning a pregnancy.
- •- Females of childbearing potential who do not agree to utilize an adequate
- •form of contraception.
- •- Current, or past history of, severe hepatic or renal impairment
- •- Current, or history within 2 months prior to the baseline of, significant
- •ocular disease
- •- Current corneal abnormalities that would prevent accurate IOP
- •readings with the Goldmann applanation tonometer.
- •- Functionally significant visual field loss
- •- Corneal thickness >600 um
- •- Contraindication to brinzolamide or sulfonamide therapy or
- •known hypersensitivity to any component of brinzolamide or
- •sulfonamide therapy
- •- Use at any time prior to baseline of an intraocular
- •corticosteroid implant.
- •- Use within 1 week prior to the baseline of contact lens
- •- Having undergone within 12 months prior to baseline
- •refractive surgery, filtering surgery, or laser surgery for
- •IOP reduction.
- •- Subjects currently in another clinical trial
研究者
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