A randomized (I: I), double-masked, multi-center, two-treatment, parallel design, multiple dose bioequivalence study with clinical endpoint comparing Bimatoprost ophthalmic solution 0.01% of Odin Pharmaceuticals Inc. with LUMIGANÂ® (Bimatoprost ophthalmic solution) 0.01 % of Allergan, Inc., Irvine, CA 92612, U.S.A in subjects with chronic open-angle glaucoma orocular hypertension in both eyes. - NA

Odin Pharmaceuticals Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 招募中
发起方

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. Subjects willing and able to provide voluntary informed consent and to follow the protocol requirements.
•2. Male or non-pregnant females aged greater than or equal to 18 years
•3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes and on prostaglandin analogue monotherapy
•4. Subjects requiring treatment of both the eyes and can discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo an appropriate washout period.
•5. Adequate wash-out period prior to baseline of any ocular hypotensive medication as per the table below (In order to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor or osmotic agent in place of a prostaglandin; however, all subjects must have discontinued all ocular hypotensive medications for the minimum washout period provided as below)
•Parasympathomimetics - 4 days
•Carbonic anhydrase inhibitors (systemic or topical) - 4 days
•Prostaglandin analogs - 4 weeks
•Osmotic agents - 4 days
•6. Baseline (Day 0 per hour 0) IOP greater than or equal to 24 mm Hg and less than or equal to 30 mm Hg in each eye and difference in IOP between the eyes is not greater than 5 mm Hg
•7. Subjects IOP is likely to be controlled with monotherapy as per the discretion of the investigator
•8. Baseline visual acuity equivalent to 20 by 80 uncorrected and 20 by 40 corrected or better in each eye
•9. Women of child-bearing potential (defined as women physiologically capable of becoming pregnant, unless they are using an effective contraception method during dosing of the investigational product) practicing any two acceptable contraception methods Acceptable methods of contraception are:
•a. Oral or parenteral (injection), patch, or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
•b. Intrauterine device or intrauterine system
•c. A double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
•d. Male sterilization (at least six months prior to the screening, should be the sole male partner for that subject)
•e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least six weeks prior to study participation
•f. Total abstinence, partial abstinence is not acceptable
•10. No history of addiction to any recreational drug or drug dependence or alcohol addiction

排除标准

•1. Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients of the formulation
•Exclusion1. Hypersensitivity to Bimatoprost or related class of drugs or any of the excipients
•of the formulation
•2. Severe hepatic or renal impairment
•3. Current or history within two months prior to the baseline of any other
•significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular
•trauma in either eye. Note: - Stable myopia, strabismus and cataracts (as per
•investigatorâ??s discretion) will be allowed provided other inclusion/exclusion
•criteria are met
•4. Current corneal abnormalities that would prevent accurate IOP readings with the
•5. Functionally significant visual field loss
•6. Use of an intraocular corticosteroid implant at any time prior to the baseline
•7. Use of contact lens within one week prior to the baseline
•8. Use of 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid within
•two weeks prior to the baseline
•9. Use of 1) systemic/ nasal corticosteroid or 2) high-dose salicylate therapy
•defined as 325mg/day taken on three consecutive days, within one month prior
•to the baseline
•10. Use of intravitreal or subtenon injection of ophthalmic corticosteroid within six
•months prior to the baseline
•11. Underwent any other intraocular surgery (e.g., cataract surgery) within six months prior to the baseline
•12. Underwent refractive surgery, filtering surgery, or laser surgery for IOP
•reduction (e.g., laser trabeculoplasty) within twelve months prior to the baseline
•13. Amblyopia/only one sighted eye
•14. Subjects with a history of IOP previously uncontrolled
•on bimatoprost monotherapy
•15. Severe retinal disease or other severe ocular pathology, such as glaucomatous
•damage with a cup/disk ratio greater than 0.8, split fixation, or functionally
•significant (in the investigatorsâ?? opinion) visual field loss
•16. Chronic use of any systemic medication that may affect IOP with less than a
•three-month stable dosing regimen (i.e., sympathomimetic agents, betaadrenergic
•blocking agents, alpha agonists, alpha-adrenergic blocking agents,
•calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.)
•17. Known history or presence of any uncontrolled systemic disease (e.g.,
•cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
•18. History of recurrent ocular seasonal allergies within the past two years
•19. Any other medical condition or severe intercurrent illness that, in the
•investigatorâ??s opinion, may make it undesirable for the subjects to participate in
•the study and would limit adherence to the studyâ??s requirements
•20. Pregnant or lactating woman
•21. Subjects with suspected signs and symptoms of COVID-19/confirmed novel
•coronavirus infection (COVID-19) or with a recent history (within 14 days) of
•contact with any COVID-19 positive subject/isolation/quarantine

研究者

发起方

Odin Pharmaceuticals Inc

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