A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
研究概览
简要总结
This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution.
详细描述
This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye. Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
The Investigator(s), Sponsor, and the subject will be masked to treatment assignment throughout the conduct of the study. Exceptions to this are limited to one statistician at the Contract Research Organization (CRO) who will prepare the randomization code, and three people at the Sponsor who will review the batch records and release product. None of these unmasked persons will be involved in the day to day execution of the study. The masking will be broken after database lock.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent prior to any study-related procedures being performed.
- •Is male or a non-pregnant, non-lactating female aged 18 years or older.
- •Willing and able to follow instructions and be present for the required study visits.
- •Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity (BCVA) of 20/200 or better in each eye.
- •Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
- •Certified as healthy by clinical assessment.
- •Verbal communication skills adequate to participate.
- •Able to tolerate bilateral instillation of Over-The-Counter artificial tear product based on investigator judgement.
排除标准
- •Have participated in an investigational study within the past 30 days.
- •Have a contraindication to local anesthetics.
- •Have known decreased corneal or conjunctival sensitivity.
- •Have had ocular surgery in either eye within the past 90 days.
- •Have had an intravitreal injection in either eye within 14 days.
- •Have ocular disease requiring punctual plugs or ocular inflammation.
- •Are currently using a systemic opioid or opiate analgesic or topical NSAID.
- •Cannot withhold their over the counter (OTC) artificial tear lubricant products for one hour preceding or following study medication.
- •Any condition, including alcohol or drug dependency, that would limit the subject's ability to comply with the procedures of the protocol.
研究组 & 干预措施
AG-920
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
干预措施: AG-920 (Drug)
Placebo
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
干预措施: Placebo (Drug)
结局指标
主要结局
The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
时间窗: 5 minutes post dose
Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."
次要结局
- How Long it Takes One Dose of AG-920 to Anesthetize the Eye(20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.)
- How Long One Dose of AG-920 Anesthetizes the Eye(20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(from randomization through study completion (up to 5 days) on average of 2 days.)
- Number of Participants With a Change in Biomicroscopy(change from baseline through end of study at Day 5)
- Change in Visual Acuity(change from baseline through end of study at Day 5)