CTRI/2024/11/076185尚未招募4 期
A Prospective, Multi-centre, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Cyclosporine 0.09% w/v Ophthalmic Solution to Increase Tear Production in Patients with Keratoconjunctivitis Sicca (Dry Eye)
Sun Pharma Laboratories Limited SPLL20 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年11月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 20
- 主要终点
- Safety:
研究概览
简要总结
This is aprospective, phase IV, single arm, multicenter, open-label study. The studywill be conducted at approximately 10-15 number of centers in India, havingqualified Investigators. The study will be initiated only after the receipt ofregulatory and ethics committee (EC) approval. After obtaining theinformed consent, patients will be screened by undergoing various assessmentsas mentioned in Schedule of Assessment. After confirming the eligibility,patients will be enrolled by allotting the enrollment number. The enrolledpatients will be given study drug Cyclosporine 0.09% w/v Ophthalmic Solution.Treatment duration will be of 84 days. During the study, assessments will beperformed as mentioned in Schedule of Assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male, and non-pregnant, non-lactating female patients of age ≥ 18 years who agree to provide written informed consent.
- •Patients with history of keratoconjunctivitis sicca (KCS) for a period of at least 6 months 3) Patients with clinical diagnosis of bilateral KCS.
- •Patients with Lissamine green conjunctival staining score of ≥ 3 to ≤
- •Patients with reported dry eye symptoms within 3 months prior to study.
- •Patients with corrected Snellen visual acuity (VA) of better than 20/200 in each eye 7) Willing to discontinue use of current therapy for KCS.
- •Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication.
- •No sperm donation is allowed during the study period.
排除标准
- •Patients using cyclosporine ophthalmic preparations within 3 months prior to the Screening Visit.
- •Patients with history of previous treatment failure with cyclosporine ophthalmic solutions.
- •Patients with clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
- •Patients using the following systemic or topical medications within 7 days prior to the Screening Visit or intended to use during the study period such as Immunomodulators, Systemic corticosteroids, Antihistamines, Cholinergics, Antimuscarinics, Tricyclic antidepressants, Phenothiazines, and Retinoids.
- •Patients using any topical ophthalmic medications, prescription or over the counter, other than the assigned study medication during the study period.
- •Patients on oral omega-3 fatty acids.
- •Patients with unstable macular disease.
- •Diagnosis of chronic uveitis or any chronic or potentially recurrent ocular condition.
- •Patients with current active eye disease other than KCS (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
- •Patients with any ocular disorder including ocular injury, infection, non-dry eye ocular inflammation, trauma, or surgery within the prior 6 months.
- •Patients with history of herpes keratitis.
- •Patients with history of corneal transplant.
- •Patients with history of corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
- •Patients who require surgical correction of dry eyes, and Contact lens wearers.
- •Patients with history of cataract surgery within 3 months prior to the Screening Visit.
- •Patients who have undergone non-laser glaucoma surgery at any time; or glaucoma laser procedures within 3 months prior to the Screening Visit.
- •Patients with lagophthalmos or clinically significant eyelid margin irregularity of either eye whether congenital or acquired.
- •Patients with history of any cancer within 5 years of screening.
- •Patients who have plans to undergo major elective surgery during the course of the study.
- •Patients with history of or currently having any of the severe/serious ocular condition or clinically significant medical conditions, such as cardiovascular, respiratory, renal, hepatic, endocrine, or gastrointestinal disease.
- •Patients with history of hypersensitivity or allergic reaction study medication or its component(s).
- •Participation in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months.
- •Investigator, study personnel, Sponsor representatives and their first degree relatives.
结局指标
主要结局
Safety:
时间窗: Day 1, Day 28, Day 56 & Day 84
Proportion of patients with treatment-emergent adverse events (TEAEs)
时间窗: Day 1, Day 28, Day 56 & Day 84
次要结局
- Efficacy:(Change from baseline in dry eye symptoms using SPEED Questionnaire score)
研究者
研究点 (20)
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