CTRI/2022/04/042203进行中（未招募）未知
A randomized, double-blind, multiple dose, parallel-group, two-arm, multicenter, bioequivalence study with clinical endpoint comparing bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
Amneal EU Limited0 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
- 进行中（未招募）
- 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 protocol requirements.
- •2. Male or females aged Greater than or equal to18 years
- •3. Subjects having body mass index (BMI) Greater than or equal to18.50 kg per m2
- •4. Subjects with chronic open angle glaucoma or ocular hypertension in both eyes
- •5. Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period
- •6. Adequate washout period prior to baseline of any ocular hypotensive medications as per the table below to minimize potential risk to subjects due to intraocular pressure 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 the subjects must have discontinued their ocular hypotensive medications for the minimum washout period provided in the table below
- •7. Baseline (Day 0 per hour 0) IOP Greater than or equal to21mm Hg and less than 34 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg
- •8. Subjects IOP is likely to be controlled with monotherapy as per the Investigators discretion
- •10. Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the following acceptable methods of contraception
- •a. Oral or parenteral injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication
- •b. Intrauterine device or intrauterine system
- •c. Double barrier method of contraception condom and occlusive cap or condom and spermicidal agent
- •d. Male sterilization at least 6 months prior to screening, should be the sole male partner for that subject
- •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
- •11. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
排除标准
- •1. Female who are pregnant, lactating or planning a pregnancy
- •2. Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation
- •3. Current or past history of severe hepatic or renal impairment
- •4. Current or history within 2 months prior to 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 the Investigatorâ??s discretion will be allowed provided that the other inclusion/exclusion criteria are met)
- •6. Functionally significant visual field loss in the Investigatorsâ?? opinion
- •7. Subject with corneal grafts
- •8. Subject has contraindication to pupil dilation
- •9. Use at any time prior to baseline of an intraocular corticosteroid implant
- •10. Use of contact lens within 1 week prior to baseline
- •11. Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid
- •13. Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid
- •14. Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery)
- •15. Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty)
- •16. Amblyopia - only one sighted eye
- •17. Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy
- •18. Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination
- •19. Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.)
- •20. History of recurrent ocular seasonal allergies within the past 2 years
- •21. Any other medical condition or serious intercurrent illness that, in the Investigatorâ??s opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements
- •22. Participation in any clinical study within 90 days before the first dose of the study drug
- •23. Subjects with documented history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection
- •24. Subjects with positive urine pregnancy test
- •25. Subjects with confirmed novel coronavirus infection (COVID-19)
研究者
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