A Randomized, Double-masked, Active Controlled, Parallel Group, Two-arm, Multi Center,in-vivo Bioequivalence Study with Clinical Endpoint Comparing Brinzolamide OphthalmicSuspension, USP 1 Percent of Riconpharma LLC, USA to AZOPT® (Brinzolamide OphthalmicSuspension) 1 Percent of Novartis Pharmaceuticals Corporation, USA in subjects with Chronic OpenAngle Glaucoma or Ocular Hypertension in both eyes - Nil

Riconpharma LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

阶段: Unknown
状态: 尚未招募
发起方: Riconpharma LLC

研究概览入排标准研究者记录与标识符相似试验

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.Male or non-pregnant female aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes.
•2.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.
•3.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.
•4.Subject has the best spectacle-corrected visual acuity (BSCVA) equivalent to 20/200 or better in each eye.
•5.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;
•MedicationMinimum 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)
•6.Subject are willing and able to provide written informed consent before any study procedures are performed.
•7.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.
•8.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
•Female subject of non-childbearing potential.
•9.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

•1.Subject with angle closure glaucoma.
•2.Females who are pregnant, breastfeeding, or planning a pregnancy.
•3.Female of childbearing potential who do not agree to utilize an adequate form of contraception.
•4.Current or past history of severe hepatic or renal impairment.
•5.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.
•6.Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
•7.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.
•8.Corneal thickness more than600 µm in either eye.
•9.History of severe dry eye in either eye.
•10.Subjects with known or suspected drug or alcohol abuse.
•11.Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy.
•12.Use at any time before the baseline of intraocular corticosteroid implant.
•13.Use within 1 week before the baseline of contact lens.
•14.Use within two weeks before baseline of 1) topical ophthalmic corticosteroid or 2) topical corticosteroid.
•15.Use within one month before baseline of 1) systemic corticosteroid or 2) high-dose salicylate therapy.
•16.Use within six months before baseline of intravitreal or subtenon injection of ophthalmic corticosteroid.
•17.Having undergone within 6 months before baseline any other intraocular surgery (e.g., cataract surgery, LASIK).
•18.Having undergone within 12 months before baseline refractive surgery, filtering surgery, or laser surgery for IOP reduction.
•19.Participating in a clinical study or therapy with an Investigational Product within the past 30 days.

研究者

发起方

Riconpharma LLC

相似试验

进行中（未招募）

1 期

A Phase 3 study to evaluate the efficacy and safety of CT-P42 versus Eylea as treatment for patients with Diabetic Macular Edema.Diabetic Macular EdemaMedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853

EUCTR2020-004278-23-SKCELLTRION Inc.360

进行中（未招募）

1 期

EUCTR2020-004278-23-DECELLTRION Inc.360

进行中（未招募）

1 期

EUCTR2020-004278-23-LTCELLTRION Inc.360

进行中（未招募）

1 期

EUCTR2020-004278-23-PLCELLTRION Inc.360

进行中（未招募）

1 期

EUCTR2020-004278-23-HUCELLTRION Inc.300