CTRI/2021/07/035089招募中未知
A randomized (1:1), double-masked, multi-center, two-treatment, parallel design, multiple dose bioequivalence study with clinical endpoint comparing Bimatoprost ophthalmic solution 0.01% ofMankind Pharma Limited, India with LUMIGAN�® (Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612, U.S.A in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. - NA
MANKIND PHARMA LIMITED INDIA0 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
- 未知
- 状态
- 招募中
- 发起方
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 to18 years
- •3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
- •4. Subjects requiring treatment of both the eyes and can discontinue use of all ocular hypotensive medications or switch ocular hypotensive medications and undergo an appropriate washout period.
- •5. Adequate wash out period prior to baseline of any ocular hypotensive medication including Parasympathomimetics, Carbonic anhydrase inhibitors, Sympathomimetics, Beta-adrenergic blocking agents, Prostaglandin analogs, Osmotic agents.
- •6. Baseline (Day 0 per hour 0) IOP greater than or equal to 22 mm Hg and less than or equal to 34 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 best-corrected visual acuity equivalent to 20/200 (6/60) 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, 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.
- •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 investigators discretion) will be allowed provided other inclusion/exclusion criteria are met.
- •4. Current corneal abnormalities that would prevent accurate IOP readings with the tonometer.
- •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 or nasal corticosteroid or 2) high-dose salicylate therapy defined.
- •as 325mg per 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 or only one sighted eye.
- •14. Subjects with a past 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 investigators 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, beta-adrenergic 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 investigatorââ?¬•s opinion, may make it undesirable for the subjects to participate in the study and would limit adherence to the studyââ?¬•s requirements.
- •20. Pregnant or lactating woman.
- •21. Subjects with suspected signs and symptoms of COVID 19 or confirmed novel coronavirus infection (COVID-19) or with a recent history (within 14 days) of contact with any COVID-19 positive subject or isolation or quarantine.
研究者
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