Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 12
- 主要终点
- To Evaluate the Change in Combined Clinical Score
研究概览
简要总结
Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.
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
- •Male or female patient ≥ 18 years of age
- •A clinical diagnosis of AIK with a minimum of a 2+ (moderate) conjunctival hyperemia and a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at least one eye
排除标准
- •Untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours or more prior to baseline visit
- •Infectious blepharitis as the primary cause of ocular hyperemia and discharge in the opinion of the investigator (Note: If the blepharitis is secondary to the conjunctivitis, the patient can be included)
- •Suspected allergic conjunctivitis as a primary cause of conjunctival hyperemia (bulbar redness) and/or discharge in the opinion of the Investigator
- •Suspected corneal ulcer
- •Ocular topical steroid use within two weeks prior to baseline visit
- •Ocular topical antibiotic use for less than 24 hours or greater than 96 hours of dosing prior to Baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics)
- •Ocular topical povidone iodine use within 1 week prior to baseline visit
- •Systemic antibiotic use within 2 weeks prior to baseline visit
- •Ocular topical or systemic anti-fungal within 2 weeks prior to baseline visit
- •Ocular topical or systemic anti-viral use within 2 weeks prior to baseline visit
- •Corticosteroid (including but not limited to oral, intranasal, inhaled, topical, etc.) or any immunosuppressant use within 30 days prior to Baseline visit
- •On current treatment for herpes keratitis (evidence of herpes keratitis and/or ocular dendrites can be included)
- •Known or suspected ocular fungal infection or ocular microsporidia infection
研究组 & 干预措施
INV-102 0.7% Three Times per Day (TID)
INV-102 ophthalmic solution administered for about 1 week
干预措施: INV-102 (Drug)
Vehicle TID
INV-102 ophthalmic solution administered for about 1 week
干预措施: Vehicle (Drug)
结局指标
主要结局
To Evaluate the Change in Combined Clinical Score
时间窗: Through End of Treatment (Day 8)
To evaluate the efficacy of INV-102 compared to vehicle control in reducing Combined Clinical Score (bulbar hyperemia plus conjunctival discharge) in patients with AIK. Conjunctival hyperemia will be rated by using the modified version of Cornea and Contact Lens Research Unit grading scale for bulbar redness, which ranges from 0 (none) to 4 points (very severe). Conjunctival discharge will be assessed using the chart below from Schwab and Friedlander (2002) to score conjunctival discharge from 0 (absent/normal) to 3 (severe).
次要结局
- To Evaluate the Percent of participants requiring rescue(Day 3)