Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cystoid macular oedema presence
研究概览
简要总结
The goal of this clinical trial is to learn which of the drugs bromfenac 0.09%, nepafenac 0.3% and diclofenac 0.1% has better efficacy in treatment and prevention of cystoid macular oedema after cataract surgery.
The main questions it aims to answer are:
Which of the drugs has better efficacy in macular oedema prevention? What medical problems do participants have when taking different drugs? Researchers will compare drugs to each other.
Participants will:
Take on of the drugs (randomized) as their treatment in preoperative and postoperative period.
Visit the clinic after the surgery on the first day, first week, in three weeks and in six weeks.
Undergo retina examination with OCT (optical coherence tomography), best vision, and fill in forms considering their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery.
- •Agree not to have any other ocular surgical procedures in the study or fellow (non study) eye within 15 days prior to the initiation of dosing with the test article or throughout the duration of the study.
- •Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
- •Are able to self administer test article (or have a caregiver available to instill all doses of test article).
排除标准
- •Have known hypersensitivity to bromfenac, nepafenac, diclofenac or any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
- •Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit.
- •Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.
- •Have used ocular, topical, or systemic NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 7 days prior to initiation of dosing with the test article or throughout the duration of study,with exception of allowing patients on a stable dose of aspirin 81 mg daily or less.
- •Have diabetes of any type.
- •Have any pathology of vitreoretinal interface (recognised on opcital coherence tomography).
- •Have any history of pars plana vitrectomy in the study eye.
- •Have glaucoma of the following types: any secondary, closed angle, severe open angle.
- •Have used ocular prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.
- •Have active corneal pathology noted in the study eye at screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Superficial punctate keratitis in study eye.
- •Have any extraocular/intraocular inflammation in the study eye at screening visit (blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis.
- •Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
- •Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
- •Are pregnant or nursing/lactating.
- •Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
研究组 & 干预措施
bromfenac 0.09%
Subjects will instill one drop into the study (operative) eye twice per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
干预措施: Bromfenac 0.09 % Ophthalmic Solution (Drug)
nepafenac 0.3%
Subjects will instill one drop into the study (operative) eye once per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
干预措施: Nepafenac 0.3% Oph Susp (Drug)
diclofenac 0.1%
Subjects will instill one drop into the study (operative) eye four times per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
干预措施: diclofenac 0.1% ophthalmic susp. (Drug)
结局指标
主要结局
Cystoid macular oedema presence
时间窗: From enrollment to the end of treatment at 6 weeks
Measured as central retinal thickness in OCT (optical coherence tomography)
次要结局
- Quality of life change with National Eye Institute Visual Function Questionnaire(From enrollment to the end of the treatment at 6 weeks.)
研究者
Tomas Vanek
Study Director
Nemocnice Kolín