A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EG017 Ointment for the Treatment of Dry Eye in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- tCFS
研究概览
简要总结
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EG017 Ointment for the Treatment of Dry Eye in Postmenopausal Women
详细描述
To evaluate the efficacy and safety of EG017 ointment for the treatment of DED in postmenopausal women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old；
- •Postmenopausal women
- •Diagnosed with DED for at least 6 months;
- •If receiving artificial tears for DED, discontinue use 1 day prior to baseline exam; if receiving other topical medications for DED, discontinue use more than 1 week or 5 half-lives (whichever is longer) prior to baseline exam; willing to discontinue use of any other topical medication for DED other than artificial tears for the entire study period;
- •6） Voluntarily participate in the trial, understand and sign written informed consent, and be willing and able to comply with the clinical trial arrangements
排除标准
- •Presence of a history of allergic reactions to the study drug, similar drugs or ingredients;
- •DED secondary to scar formation (e.g., radiation therapy, alkali burns, Stevens-Johnson syndrome, scar-like aspergillosis) or conjunctival cupped cell destruction (e.g., vitamin A deficiency);
- •Screening slit lamp examinations reveal clinically significant ocular disease or abnormalities in the ocular anatomy
- •Schirmer test (without anesthesia) < 3mm/5min；
- •Screening stage CFS revealed a lamellar defect in the corneal epithelium or ≥ 2 areas of corneal staining fusion > 50%;
- •BCVA ≤ 0.2 in both eyes during the screening period;
- •Presence of active ocular or periocular acne, ocular allergies and ocular infections at the time of screening, which in the judgment of the investigator may interfere with the test;
- •History of corneal contact lens wear within 1 month prior to screening, or inability to stop wearing corneal contact lenses during the screening period to the end of the study;
- •History of treatment with topical steroids, topical NSAIDs, topical cyclosporine, lifitegrast, tacrolimus, serum tears, or topical antiglaucoma medications within 1 month prior to screening;
- •Have received or had removed a permanent lacrimal embolus within 1 month prior to screening, or plan to have a lacrimal embolus installed or related to removal of a lacrimal embolus during the study, or plan to have a lacrimal embolus lysed during the study;
- •LipiFlow treatment within 3 months prior to screening, or intense pulsed light treatment within 1 month prior to screening, or blepharoplasty within 1 week prior to screening;
- •History of intraocular surgery or ocular laser surgery within 6 months prior to screening, or planned ocular or eyelid surgery during the study period;
- •Presence of a history of herpetic keratitis, ocular or periocular malignancy;
- •Presence of an infection requiring systemic antibiotic (including antibacterial, antiviral, antifungal) control within 7 days prior to screening;
- •Severe systemic autoimmune diseases;
- •Presence of the clinically significant diseases；
- •Participated in other drug or device clinical trials within 1 month prior to screening;
- •Any medical or other condition that the investigator believes may affect the clinical trial.
研究组 & 干预措施
EG017 ointment 3%
60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
干预措施: EG017 ointment (Drug)
EG017 ointment 5%
60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
干预措施: EG017 ointment (Drug)
EG017 ointment 9%
60 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
干预措施: EG017 ointment (Drug)
Placebo A
40 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
干预措施: EG017 ointment placebo (Drug)
Placebo B
20 subjects，Apply once a night on the skin side of both eyelids at bedtime, approximately 100 mg/eye per dose, for 8 weeks
干预措施: EG017 ointment placebo (Drug)
结局指标
主要结局
tCFS
时间窗: 8 weeks
Change from baseline in tCFS（Total corneal fluorescein staining）after 8-week of treatment
次要结局
未报告次要终点