CTRI/2024/07/071413招募中不适用
A Randomized, Double-masked, Active Controlled, Parallel Group, Two-arm, Multi Center, in-vivo Bioequivalence Study with Clinical Endpoint Comparing Brinzolamide Ophthalmic Suspension, USP 1 Percent of Riconpharma LLC, USA to AZOPT® (Brinzolamide Ophthalmic Suspension) 1 Percent of Novartis Pharmaceuticals Corporation, USA in subjects with Chronic Open Angle Glaucoma or Ocular Hypertension in both eyes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 13
- 主要终点
- The mean difference in Intraocular Pressure (IOP) of both eyes between the treatment groups at four point at 08:00 AM ± 30 minutes and at 10:00 AM ± 30 minutes using the Goldmann applanation tonometer at the baseline visit (Visit 2) and at Day 14 (Week 2) and Day 42 (Week 6) visits.
研究概览
简要总结
Sponsor is developing a generic version of Brinzolamide Ophthalmic Suspension, USP 1%. The proposed study is designed in compliance with the current product specific guidance published by the Office of Generic Drugs (OGD), US FDA to establish bioequivalence for the sponsor’s Brinzolamide Ophthalmic Suspension, USP 1% compared to AZOPT® (Brinzolamide Ophthalmic Suspension) 1% of Novartis Pharmaceuticals Corporation USA.
This is a randomized, double-masked, active controlled, parallel group, two-arm, multi center, in-vivo bioequivalence study with clinical endpoint comparing Brinzolamide Ophthalmic Suspension, USP 1% of Riconpharma LLC, USA to AZOPT® (Brinzolamide Ophthalmic Suspension) 1% of Novartis Pharmaceuticals Corporation, USA in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Male or non-pregnant female aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes.
- •Subject requires treatment of both eyes and is able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
- •Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
- •Subject has the best spectacle-corrected visual acuity (BSCVA) equivalent to 20/200 or better in each eye.
- •Adequate wash-out period prior to the baseline of any ocular hypotensive medication.
- •To minimize potential risk to the subject due to intraocular pressure (IOP) elevations during the washout period, the investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandins; however, the subject must have discontinued all ocular hypotensive medication for the minimum washout period provided in the table below; Medication Minimum Washout Period Parasympathomimetics (e.g., pilocarpine, carbachol) 4 days Carbonic anhydrase inhibitors (systemic or topical) (e.g., acetazolamide, dorzolamide hydrochloride, and brinzolamide) 4 days Sympathomimetics (e.g., dipivefrin, and epinephrine) 2 weeks (14 days) Alpha-agonists (e.g., apraclonidine, brimonidine tartrate, brimonidine tartrate/brinzolamide) 2 weeks (14 days) Beta-adrenergic blocking agents (e.g., timolol, timolol maleate, dorzolamide hydrochloride, timolol maleate and brimonidine tartrate, levobunolol, betaxolol, metipranolol, carteolol) 4 weeks (28 days) Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost, and tafluprost) 4 weeks (28 days)
- •Subject are willing and able to provide written informed consent before any study procedures are performed.
- •Subject willing and able to understand and comply with the requirements of the study, consume the Investigational Product as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.
- •Female subject of childbearing potential practicing an approved method of contraception and willing to continue its use from study entry to the end of the study and have a negative Urine Pregnancy Test at the time of screening or Female subject of non-childbearing potential.
- •Male subjects must use accepted methods of birth control or must agree to practice abstinence from study entry to the end of the study.
排除标准
- •Subject with angle closure glaucoma.
- •Females who are pregnant, breastfeeding, or planning a pregnancy.
- •Female 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 before baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
- •Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
- •Patients with severe central visual field loss in either eye; severe central visual field loss was defined as a sensitivity of less than or equal to 10dB in at least 2 of the 4 visual field test points closest to the point of fixation.
- •Corneal thickness more than600 µm in either eye.
- •History of severe dry eye in either eye.
- •Subjects with known or suspected drug or alcohol abuse.
- •Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy.
- •Use at any time before the baseline of intraocular corticosteroid implant.
- •Use within 1 week before the baseline of contact lens.
- •Use within two weeks before baseline of 1) topical ophthalmic corticosteroid or 2) topical corticosteroid.
- •Use within one month before baseline of 1) systemic corticosteroid or 2) high-dose salicylate therapy.
- •Use within six months before baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
- •Having undergone within 12 months before baseline refractive surgery, filtering surgery, or laser surgery for IOP reduction.
- •Participating in a clinical study or therapy with an Investigational Product within the past 30 days.
结局指标
主要结局
The mean difference in Intraocular Pressure (IOP) of both eyes between the treatment groups at four point at 08:00 AM ± 30 minutes and at 10:00 AM ± 30 minutes using the Goldmann applanation tonometer at the baseline visit (Visit 2) and at Day 14 (Week 2) and Day 42 (Week 6) visits.
时间窗: Day 2 and Day 14
次要结局
- NA(NA)
研究者
Dr D Sathish Kumar
G7 Synergon Private Limited
研究点 (13)
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