A Randomized, Parallel, Single-Center, Double-Masked, Vehicle-Controlled Phase II Study to Evaluate the Activity of NS2 Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Provocation Test (CAPT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
研究概览
简要总结
This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%).
Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of >2
- •Graded ocular itching at any one time point
- •Visual acuity of at least 20/50 in each eye
- •At least 2 year history of moderate to severe allergic conjunctivitis.
- •Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1).
- •Ability to avoid any topical or systemic ocular medications during the entire study period.
排除标准
- •Subjects must not have an ocular itching score >0 or a conjunctival redness score >1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-
- •History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
- •Ocular surgery, including laser procedures, within the past 12 months of Visit
- •Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit.
- •History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
- •History of uveitis in the past 3 years.
- •Presence of any ocular infection or active ocular inflammation (e.g. follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to start of study (Visit 1).
- •History of moderate to severe asthma or allergy induced asthma to the allergen that will be used in CAPT.
- •Use of oral corticosteroids within 30 days of screening and throughout the study period; use of intranasal or inhaled corticosteroids within 14 days of screening and throughout the study period.
- •Use of antihistamines (ocular, nasal, topical or oral) within 7 days prior to screening (Visit 1) and throughout the study period. Non-medicated artificial tears are allowed up to 72 hours before screening (Visit 1) and throughout the study period.
研究组 & 干预措施
NS2 Ophthalmic Drops (0.5%)
NS2 Ophthalmic Drops (0.5%)
干预措施: NS2 Ophthalmic Drops (0.5%) (Drug)
NS2 Ophthalmic Drops Vehicle (0.0%)
NS2 Ophthalmic Drops Vehicle (0.0%) control
干预措施: NS2 Ophthalmic Drops Vehicle (0.0%) (Drug)
结局指标
主要结局
Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
时间窗: The efficacy assessment period was assessed at Day 14; baseline was Day -7.
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
次要结局
未报告次要终点