CTRI/2020/01/022619已完成3 期
A Comparative, Randomized, Two Arm, Double Blind, Parallel Group, Multicentric, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Netarsudil Ophthalmic Solution 0.02% w/v Versus Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 8
- 主要终点
- Mean Reduction in IOP at the end of 12 weeks of treatment as compared to baseline at 9.00 AM, 11.00 AM and 5.00 PM
研究概览
简要总结
A Comparative, Randomized, Two Arm, Double Blind, Parallel Group, Multicentric, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Netarsudil Ophthalmic Solution 0.02% w/v Versus Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension.
recrutment started on January 06,2020 and study has completed on 28 Aug 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •Subjects meeting all of the following criteria will be recruited for the trial 1.Male and Female subjects between 18 – 65 years of age (both inclusive).
- •2.Newly diagnosed patients of primary open angle glaucoma / ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry.
- •3.Subjects with IOP between 22 mmHg – 27 mmHg at the time of screening in any one eye.
- •In case both the eyes of a single subject are affected then the eye fulfilling the criteria will be considered for the evaluations.
- •If both eyes are fulfilling the criteria, then the right eye will be considered for the study.
- •4.Visual acuity 6/60 or better.
- •5.Voluntary willingness of patient to give written informed consent prior to participation in trial.
排除标准
- •Subjects will be excluded if ANY of the following conditions apply: Ophthalmic: 1.Subjects with any severe or advanced cases of Glaucoma 2.Shaffer angle grade ≤ 2 in either eye, as measured by Gonioscopy 3.Subjects with pseudoexfoliation or pigment dispersion component glaucoma 4.Subjects who are blind or subjects who have a single eye.
- •5.Severe central visual field loss in either eye measured by Perimetry 6.Cup/disc ratio greater than 0.80 7.Current or history within three months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
- •8.Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
- •9.Subject who have history of any ocular surgery in either eye in past (e.g. peripheral iridotomy, glaucoma incisional or laser surgery, refractive surgery) or are planning to undergo any ocular surgery during study period 10.Subjects having central corneal thickness greater than 600 mm in either eye 11.History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
- •12.Subjects using contact lenses.
- •13.Contraindication or hypersensitivity to any component of study medication 14.Subject having history of chronic use of any ocular medication 15.Subjects having local administration of corticosteroids injections in the eye Others: 16.Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy or 3) Oral carbonic anhydrase inhibitor 17.Females who are pregnant, breast feeding, or planning a pregnancy.
- •18.Females of childbearing potential who do not agree to utilize an adequate form of contraception 19.Subjects with history of CVS, Hepatic, Psychiatric, Cancer or Renal diseases which could be considered significant for the subject to be enrolled in the study.
- •20.Subjects with/history of Bronchial Asthma, bronchial hyper reactivity or severe COPD that would preclude the safe administration of a topical beta blocker.
- •21.Subjects on these listed medications will be excluded from the study: a) High-dose (>1 gm daily) salicylate b) Topical as well as Oral β-Blockers c) alpha agonists and blockers d) ACE inhibitors and calcium channel blockers e) Systemic administration of corticosteroids or immunosuppressive agents.
- •22.Participation in any clinical study within 30 days prior to entry into the study.
- •23.Subject not willing to comply with the study protocol and does not provide written informed consent to participation 24.Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e. defined as Glycosylated HbA1C Level >7%).
结局指标
主要结局
Mean Reduction in IOP at the end of 12 weeks of treatment as compared to baseline at 9.00 AM, 11.00 AM and 5.00 PM
时间窗: Day 0 and Day 84
次要结局
- Mean Reduction in IOP at the end of 4 weeks of treatment as compared to baseline(Mean Reduction in IOP at the end of 8 weeks of treatment as compared to baseline.)
研究者
研究点 (8)
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