A Multicenter, Randomized, Double-Masked, Active-Controlled Study to Evaluate the Safety and Efficacy of LME636 in Patients With Acute Anterior Uveitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Number of Responders at Day 15
研究概览
简要总结
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).
详细描述
Eligible subjects will be randomized to LME636 or Dexamethasone in a 3:1 ratio at the time they present to the trial site with the AAU flare and will enter treatment for 28 full days. Subjects with worsening disease from Visit 2/Day 4 onward or subjects without improvement after 14 days of treatment will be discontinued from treatment, unmasked and treated with a rescue regimen at the discretion of the investigator.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Diagnosis of non-infectious AAU in at least 1 eye.
- •Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature (SUN) in at least one eye.
- •Able to communicate well with the Investigator, to understand and comply with the requirements of the study.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol.
- •AC cell score of 4+ (SUN) or hypopyon.
- •Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.
- •Presence of intermediate-, posterior-, or panuveitis in either eye.
- •Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as described in the protocol.
- •Recurrent corneal abrasion or ulceration in either eye (past or present).
- •Tuberculosis (past or present).
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
LME636
LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
干预措施: LME636 60 mg/mL ophthalmic solution (Drug)
LME636
LME636 60 mg/mL ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 1 week (Week 3) and 1 week of masked Vehicle administration (Week 4)
干预措施: LME636 Vehicle (Drug)
Dexamethasone
Dexamethasone 0.1% ophthalmic solution, maximum drop frequency administered for 2 weeks, followed by a tapering for 2 weeks (Weeks 3 and 4)
干预措施: Dexamethasone 0.1% ophthalmic solution (Drug)
结局指标
主要结局
Number of Responders at Day 15
时间窗: Baseline (Day 1), Day 15
Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.
Mean Best Corrected Visual Acuity (BCVA) at Each Visit
时间窗: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.
Mean Intraocular Pressure (IOP) at Each Visit
时间窗: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.
Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit
时间窗: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.
Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit
时间窗: Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29
The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.
次要结局
- Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment(Baseline (Day 1), Up to Day 29)
- Mean Change From Baseline in BCVA at Each Visit(Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29)
- Time-to-Response(Baseline (Day 1), Up to Day 15)
- Use of Rescue Treatment(Day 4, Day 8, Day 15)
- Mean Serum Concentration of Total LME636 at Each Visit(Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29)
- Number of Subjects With Anti-LME636 Antibodies Present at Each Visit(Day 1, Day 4, Day 8, Day 15, Day 22, Day 29)