A Prospective, Randomized, Double-Masked, Vehicle and Active-Controlled, Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for the Treatment of Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
研究概览
简要总结
The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.
详细描述
Eligible subjects attended 8 study visits, 5 of which included a 3-hour period of ragweed exposure in an Environmental Exposure Chamber. At the sixth visit, subjects received study product and began dosing for up to 9 days. The final visit was the final day of dosing. Participation in this study lasted up to 68 days.
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
- •Sign Informed Consent
- •Use of condom by sexually active males for the entire duration of the study.
- •Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
- •Able and willing to comply with study protocol and follow protocol instructions.
- •Able to avoid any of the topical ocular or systemic excluded medications during the entire study period.
- •At least 1 year subject-reported or physician-diagnosed history (prior to Screen Visit) of allergic conjunctivitis during the ragweed season.
- •Positive skin prick test for short ragweed allergen within 12 months prior to Screen Visit.
- •Significant staff-assessed ocular redness in at least one region in each eye within the 3 hour period of allergen exposure in the EEC (Screen Visits).
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 1 week following the last dose of investigational product.
- •Presence of any ocular infection, history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye.
- •History of any ocular infection, physician or subject diagnosed, within 30 days prior to Screen Visit.
- •Presence of glaucoma, past history of, or diagnosis of glaucoma or ocular hypertension.
- •Presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular lymphadenopathy or any other ophthalmic abnormality that may affect the study outcomes.
- •Corneal conditions affecting the corneal structure.
- •Unwilling to discontinue contact lens wear during the study period.
- •Any ocular surgery including ocular laser procedures within 1 year prior to Screen Visit.
- •Current or recent (<6 months prior to Screen Visit) history of severe, unstable, or uncontrolled autoimmune, neurological, cardiovascular, hematological, hepatic, renal, psychological, respiratory, gastrointestinal and/or immunological disease or evidence of other diseases based upon a review of medical history and/or physical examination that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- •Receiving treatment for anxiety and/or depression at the Screen Visit; any history of suicide attempt.
- •Participation in any investigational study within 30 days of Screen Visit or concomitantly with this study.
- •Known contraindications or hypersensitivities to any of the study medications or their components
- •Confirmed (by physician or optometrist) diagnosis of dry eye.
- •History of sensitivity or adverse reaction to steroids.
- •Known allergic reaction that is unresponsive to corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDS).
- •Physician diagnosed asthma (except inactive childhood asthma and exercise-induced asthma).
- •Evidence of active inflammation in the eye as determined by the dilated fundus examination conducted at Screen C Visit.
- •Any corneal swelling or haze as determined by the slitlamp examination conducted at Screen C Visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-53817
AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
干预措施: AL-53817 Ophthalmic Solution, 0.1% (Drug)
AL-78843
AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
干预措施: AL-78843 Ophthalmic Solution, 0.03% (Drug)
Maxidex
Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
干预措施: Dexamethasone Ophthalmic Suspension, 0.1% (Drug)
Vehicle
AL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
干预措施: AL-53817 Vehicle (Drug)
结局指标
主要结局
Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
时间窗: 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7
Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis.
次要结局
- Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7(0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7)