CTRI/2020/03/024026已完成不适用
A Randomized (1:1), double-masked, multi-center, two-treatment, single-period, parallel design, multiple dose, comparative study with clinical endpoint of Bimatoprost ophthalmic solution 0.01% of Mankind Pharma Limited, India with LUMIGAN® (Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612, U.S.A in patient with chronic open-angle glaucoma or ocular hypertension in both eyes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups
研究概览
简要总结
A Randomized (1:1),double-masked, multi-center, two-treatment, single-period, parallel design,multiple dose, comparative study with clinical endpoint of Bimatoprostophthalmic solution 0.01% of Mankind Pharma Limited, India with LUMIGAN®(Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612,U.S.A in patients with chronic open-angle glaucoma or ocular hypertension in botheyes.
Primary Objective: To compare Bimatoprostophthalmic solution 0.01% of Mankind Pharma Limited, India with LUMIGAN®(Bimatoprost ophthalmic solution) 0.01% of Allergan, Inc., Irvine, CA 92612,U.S.A
SecondaryObjective: To monitor the adverse events and to ensurethe safety of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The subjects must meet all of the following inclusion criteria: 1.Patient willing and able to provide voluntary informed consent and to follow the protocol requirements. 2.Male and female patient aged Greater or equal to18 years having body mass index BMI Greater or equal to 17 calculated as weight in kg per height in m
- •3.Patients with chronic open angle glaucoma or ocular hypertension in both eyes. 4.Patient requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo 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 patients 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 prostaglandin; however, all patients must have discontinued all ocular hypotensive medication for the minimum washout period provided below a. Parasympathomimetics [e.g., pilocarpine, carbachol].
- •4 days b. Carbonic anhydrase inhibitors (systemic or topical) [e.g., acetazolamide, dorzolamide hydrochloride, brinzolamide].
- •4 days c. Sympathomimetics [e.g., dipivefrin, epinephrine].
- •2 weeks d. Alpha-agonists [e.g., apraclonidine, brimonidine tartrate, brimonidine tartrate and brinzolamide].
- •2 weeks e. Beta-adrenergic blocking agents [e.g., timolol, timolol maleate and dorzolamide hydrochloride, timolol maleate and brimonidine tartrate, levobunolol, betaxolol, metipranolol, carteolol].
- •4 weeks f. Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost, tafluprost].
- •4 weeks g. Osmotic agents.
- •4 days 6.Baseline (Day 0/hour 0) IOP Greater or equal to 22 mm Hg and Less than or equal to 34 mm Hg in each eye and difference between IOP in the left and right eye is not greater than 5 mm Hg. 7.Baseline best corrected visual acuity equivalent to 20/200 (6/60) or better in each eye. 8.Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception. 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 deviceIUD or intrauterine system IUD or IUS c. Double barrier method of contraception Condom and occlusive cap or condom and spermicidal agent d. Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) e. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation f. Total abstinence, partial abstinence is not acceptable. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •The subjects must not meet any of the following exclusion criteria: 1.Hypersensitivity to Bimatoprost or related class of drugs or to any of the excipients of the formulation. 2.Current or history within two months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye. 3.Corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer. 4.Functionally significant visual field loss. 5.Use at any time prior to baseline of an intraocular corticosteroid implant. 6.Use of contact lens within one week prior to baseline. 7.Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid 8.Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy defined as 325mg taken on three consecutive days. 9.Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid. 10.Underwent within six months prior to baseline any other intraocular surgery (e.g., cataract surgery) 11.Underwent within twelve months prior to baseline: refractive surgery, filtering surgery or laser surgery for IOP reduction 12.Amblyopia.
- •only one sighted eye 13.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 14.Chronic use of any systemic medication that may affect IOP with less than 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.) 15.History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment etc.) 16.History of recurrent ocular seasonal allergies within the past 2 years 17.Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV). 18.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study that would limit adherence to study requirements 19.Participation in any clinical study within 90 days before the first dose of Investigational Product. 20.Pregnant or lactating woman.
结局指标
主要结局
Mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups
时间窗: Day: 00, Day: 14 ± 3, Day : 42 ± 3 - 00.00 hour (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours ± 30 minutes after 00.00 hours), 08.00 hours (at 8 hours ± 30 minutes after 00.00 hours)
次要结局
- Incidence of treatment-emergent serious and non-serious adverse events (AEs)(Day: 00, Day: 14 ± 3, Day : 42 ± 3 - 00.00 hour (between 8:00 am and 10:00 am), 04.00 hours (at 4 hours ± 30 minutes after 00.00 hours), 08.00 hours (at 8 hours ± 30 minutes after 00.00 hours))
研究者
研究点 (5)
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