CTRI/2024/07/070446尚未招募3 期
A Multi-Center, Double-Blind, Randomized, Active-Controlled, Comparative, Parallel-Group, Phase III Clinical Study to Evaluate the efficacy and safety of FDC of Netarsudil and Latanoprost Ophthalmic Solution with monotherapy of Netarsudil Ophthalmic Solution and Latanoprost Ophthalmic Solution in patients with open-angle glaucoma or ocular hypertension.
MsPure And Cure Healthcare PvtLtd7 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2024年7月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 216
- 试验地点
- 7
- 主要终点
- To evaluate efficacy of Fixed Dose Combination of Netarsudil 0.02% plus Latanoprost0.005% w/v Ophthalmic Solution in comparison to monotherapy of Netarsudil 0.02% w/v Ophthalmic Solution and Latanoprost 0.005% w/v Ophthalmic Solution for the treatment of elevated intraocular pressure with open angle glaucoma or ocular hypertension patients.
研究概览
简要总结
This is a Multi-Center, Double-Blind, Randomized, Active-Controlled, Comparative, Parallel-Group, Phase III Clinical Study to Evaluate the intraocular pressure (IOP)-lowering efficacy and safety of FDC of Netarsudil and Latanoprost Ophthalmic Solution with monotherapy of Netarsudil Ophthalmic Solution and Latanoprost Ophthalmic Solution in patients with open-angle glaucoma or ocular hypertension.
Male and non-pregnant, non-lactating female subjects, 18 to 65 years of age (both inclusive), for the treatment of elevated intraocular pressure with open angle glaucoma or ocular hypertension patients.
Study Period: Total study duration for the clinical part shall be of 12 weeks
This Phase III study consists of following visits.
• Visit 1: Screening Visit (Day -28 to Day 0)
• Visit 2: Randomization/Baseline Visit (week0/Day 1)
• Visit 3: Interim Visit (Week 4/Day 28 ± 2 days)
• Visit 4: Interim Visit (Week 8/Day 56 ± 2 days)
• Visit 5: End of Study/Early Discontinuation Visit (12 weeks/Day 84 ± 4 days)
After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. At randomization/baseline visit, subjects shall be randomly assigned (Double-blind) in 1:1:1 fashion to one of the three treatments. Approximately 216 patients shall be enrolled/randomized.
Study Period: Total study duration for the clinical part shall be of 12 weeks
Safety Parameter: Safety will be assessed by the monitoring of adverse clinical events and physical examinations. All AEs & SAEs occurring during the study will be recorded and reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients of either sex aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
- •Diagnosis (new/old) of primary open angle glaucoma/ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry
- •IOP values a.
- •Newly diagnosed.
- •IOP Greater-than 20 mmHg and Less-than 36 mmHg at 9 AM in at least one eye at screening and day 1 (randomization day) b.
- •Old patients.
- •Unmedicated (post-washout (refer note)) IOP Greater-than 20 mmHg and Less-than 36 mmHg at 9 AM in at least one eye at day 1 (randomization day) For purposes of determining eligibility of subjects to be randomized, IOP number should not be rounded off.
- •Best corrected visual acuity Plus 1.0 logMAR or better by ETDRS in each eye (equivalent to 20 by 200 (6 by 60) or better Snellen visual acuity in each eye)
- •Patients presenting with mild or moderate severity of glaucoma (as per ICMR guidelines).
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing (oral, intravaginal, or transdermal) or progesterone only (oral, injectable, or implantable) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence) (Note Woman with childbearing potential are defined as those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal).
- •A female patient of non-childbearing potential such as (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
- •(Note Post-menopausal woman will be defined as Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age) Note Ocular Hypotensive Medication Washout Period Prostaglandin analogues- 4 weeks β-adrenoceptor antagonists- 4 weeks Adrenergic agonists (including α-agonists such as brimonidine and apraclonidine)- 2 weeks Muscarinic agonists (eg, pilocarpine), carbonic anhydrase inhibitors (topical or oral)- 5 days.
排除标准
- •1.Clinically significant ocular disease (eg, corneal edema, uveitis, or severe keratoconjunctivitis sicca) which might interfere with interpretation of the study efficacy endpoints or with safety assessments, including subjects with glaucomatous damage based on field effect so severe that washout of ocular hypotensive medications for 1 month is not judged safe as it would put the subject at risk for further vision loss.
- •(The Investigator will be encouraged to conduct interim visits (unscheduled visits) during the washout period for IOP measurements for individuals to whom a washout period may be a risk for further glaucomatous progression).
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles (i.e., Shaffer Grade 2 or less extreme narrow angle with complete or partial closure).
- •Note , Previous laser peripheral iridotomy is NOT acceptable.
- •Use of more than two ocular hypotensive medications within 28 days of screening.
- •Note fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication
- •Known hypersensitivity to any component of the investigational formulations or to Latanoprost
- •Patients with COVID-19 signs and symptoms
- •Previous glaucoma intraocular surgery, including SLT or ALT in either eye
- •Refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking)
- •Ocular trauma within six months prior to screening, or ocular surgery or non-refractive laser treatment within three months prior to screening.
- •Recent or current evidence of ocular infection or inflammation in either eye.
- •Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, or a history of herpes simplex or zoster keratitis in either eye at screening
- •Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study), or d) non-steroid allergy drops (note.
- •must not contain a vasoconstrictor) as prescribed by the Investigator.
- •Any abnormality preventing reliable applanation tonometry of either eye (eg, keratoconus)
- •Subjects with known case of any severe or advanced cases of Glaucoma as per investigator discretion
- •Subjects who are blind or subjects who have a single eye
- •History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- •Subjects using contact lenses.
- •Subjects having local administration of corticosteroids injections in the eye
- •Systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study, including any corticosteroid-containing drug regardless of route of administration
- •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
- •Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e., HbA1c Level greater than 7 percentage).
- •Patients with any clinically significant lab abnormalities by condition which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements
- •Pregnant or lactating women
- •Patient with known alcohol or other substance abuse within last one year as per DSM -5 criteria.
- •Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
- •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.
结局指标
主要结局
To evaluate efficacy of Fixed Dose Combination of Netarsudil 0.02% plus Latanoprost0.005% w/v Ophthalmic Solution in comparison to monotherapy of Netarsudil 0.02% w/v Ophthalmic Solution and Latanoprost 0.005% w/v Ophthalmic Solution for the treatment of elevated intraocular pressure with open angle glaucoma or ocular hypertension patients.
时间窗: Visit 1: Screening Visit (Day -28 to Day 0), Visit 2: Baseline Visit (week0/Day 1),Visit 3: (Week 4/Day 28 ± 2 days),Visit 4: (Week 8/Day 56 ± 2 days),Visit 5: End of Study/Early Discontinuation Visit (12 weeks/Day 84 ± 4 days).
次要结局
- To evaluate safety of Fixed Dose Combination of Netarsudil 0.02% plus Latanoprost 0.005 percentage w/v Ophthalmic Solution in comparison to monotherapy of Netarsudil 0.02% w/v Ophthalmic Solution and Latanoprost 0.005 percentage w/v Ophthalmic Solution for the treatment of elevated intraocular pressure with open angle glaucoma or ocular hypertension patients.(Patients shall complete five scheduled clinic visits as follows:)
研究者
Dr Aditi Datta
Biosite Research Private Limited
研究点 (7)
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