Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Flare in Anterior Chamber
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
详细描述
Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation.
This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 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
- •Patients older than 18 years who require cataract surgery
- •Both genders
- •Provide informed consent
- •Normal Laboratory results
排除标准
- •Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery
- •Patients with any trans-surgical complication
- •Patients with a cataract >NC4, C4 or P4 classified with the system LOCS
- •Patients with any active corneal pathology
- •Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin)
- •Patients with IOP <5 or >21 mmHg
- •Patients that have ocular pain, cellularity or flare at the moment of selection
- •Patients with ocular exfoliation, trauma or any inflammatory disease
- •Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus
- •Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye
- •Patients with history of hypersensitivity or contraindication for any drug used in the study
- •Patients under anticoagulant treatment
- •Contact lens users
- •Pregnant patients, at risk of pregnancy or breastfeeding
- •Patients without birth control treatment
- •Patients with any active toxicomania (alcoholism, cigarette, cannabis or others)
- •Patients who had participated in any clinical trial in the last 90 days
- •Legal or mentally disabled patients who could not give informed consent
- •Patients who cannot comply with all study requirements
研究组 & 干预措施
Nevanac
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
干预措施: Nevanac (Drug)
PRO-155
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
干预措施: PRO-155 (Drug)
结局指标
主要结局
Flare in Anterior Chamber
时间窗: day 30
Percentage of Participants with flare in anterior chamber after 30 days of treatment
Percentage of Cellularity in Anterior Chamber
时间窗: day 30
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
次要结局
- Percentage of Patients Without Ocular Pain(day 30)
- Mean Aqueous Concentration of Intervention Drug(before surgery)