CTRI/2015/05/005760Other3 期
A randomized, multicenter, prospective, parallel group, double-blind, three arm, comparative study to compare the efficacy and safety of Brinzolamide 1% ophthalmic suspension of Cipla Ltd., India against Azopt® manufactured by Alcon Pharma Ltd., US in subjects with chronic open angle glaucoma or ocular hypertension
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- Cipla Ltd
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.Written, signed, dated and ethics committee approved informed consent obtained from subjects and/or legally acceptable representative, along with the audio-video recording of the process, before performing any screening procedures
- •2.Male or non-pregnant females of age 18 to 65 years [both inclusive] with chronic open angle glaucoma or ocular hypertension in both eyes on stable ocular hypotensive treatment regimen
- •3.Subject 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
- •4.Adequate wash-out period prior to baseline of any ocular hypotensive medication (see Table 1). In order to minimize potential risk to patients due to IOP elevations during the washout period, 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 in Table 1.
- •5.Baseline (Day 0/hour 0) IOP >= 22 mm Hg and <= 34 mm Hg in each eye and any asymmetry of IOP between the eyes which is no greater than 5 mm Hg.
- •6.Baseline best corrected visual acuity equivalent to 20/200 or better in each eye.
排除标准
- •1.Females who are pregnant, breast feeding, or planning a pregnancy.
- •2.Females of childbearing potential who do not agree to utilize an adequate form of contraception.
- •3.Current or past history of severe hepatic or renal impairment.
- •4.Current or history of significant ocular disease within two months prior to baseline e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
- •5.Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
- •6.Functionally significant visual field loss.
- •7.Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy.
- •8.Use of intraocular corticosteroid implant at any time prior to baseline.
- •9.Use of contact lens within one week prior to baseline.
- •10.Use of: a) topical ophthalmic corticosteroid, or b) topical corticosteroid within two weeks prior to baseline.
- •11.Use of: a) systemic corticosteroid or b) high-dose salicylate therapy within one month prior to baseline.
- •12.Use of intravitreal or subtenon injection of ophthalmic corticosteroid within six months prior to baseline.
- •13.Performance of any other intraocular surgery (e.g., cataract surgery) within six months prior to baseline
- •14.Performance of refractive surgery, filtering surgery or laser surgery for IOP reduction within twelve months prior to baseline
- •15.History of alcohol, chemical or drug abuse or dependence as per DSM IV criteria
- •16.Serologic positivity for the Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV)
- •17.Current active malignancy or history of malignancy within the past five years
- •18.Any other clinically significant abnormal medical condition that in the Investigators judgement would put the patient at increased risk of illness or injury would interfere with study participation or would interfere with the evaluation or quality of the data.
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