Efficacy and Safety of Difluprednate Ophthalmic Emulsion vs. a Fixed-Combination of Prednisolone Acetate - Phenylephrine Ophthalmic Suspension on Post-operative Inflammation Following Cataract Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Change from baseline corneal thickness between treatments
研究概览
简要总结
This controlled, randomized, double blind, multicenter study will be carried out to demonstrate that the topical ophthalmic nanoemulsion of difluprednate 0.05% (Tolf®, Poen Laboratories), has a high anti-inflammatory efficacy, which would allow it to be administered after cataract surgery 1 drop, twice a day , starting the day before surgery and continuing for 14 days and 1 drop, once a day for the following 2 weeks, achieving an adequate anti-inflammatory activity, with the benefit of reducing the toxicity on the ocular surface, improving the dosage and adherence to treatment.
The follow-up time will be 28 days and the outcome measures will be evaluated in a baseline (time 0), on day 1, on day 4 and on day 28 after surgery. The active control will be prednisolone acetate 1% + phenylephrine hydrochloride 0.12% topical ophthalmic suspension (Prednefrin® Forte, Allergan Argentina) given 1 drop, 4 times a days and 1 drop, twice a day for the next 2 weeks. Corneal thickness, central macula thickness, endothelial cell count, intraocular pressure, visual acuity, anterior chamber clearance and lacrimal film recovery will be evaluated.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes between 45 and 65 years old (women who are not fertile) who undergo cataract surgery N2 and N3, defined according to BCN10, Decimal classification of cataracts.
- •That the surgical technique is ultrasonic phacoemulsification.
- •Patients who have an initial corneal thickness between 500 and 570 µm inclusive.
- •Patients with initial intraocular pressure between 12 and 18 mm Hg inclusive.
- •Patients with an endothelial cell count greater than 1000 cells / mm2
排除标准
- •Patients who use eye medication, except eye lubricant.
- •Patients who before surgery have not been able to dilate their pupil more than 5 mm
- •Patients who have been treated with corticosteroids or systemic anti-inflammatory drugs for 2 weeks prior to enrollment
- •Patients who have received periocular corticosteroid injections in the study eye within the previous 4 weeks or used depot corticosteroids within 2 months prior to enrollment
- •Patients who have received a topical ocular corticosteroid or non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to enrollment
- •History of glaucoma or ocular hypertension in the study eye, history or presence of endogenous uveitis, or corneal abrasion or ulceration
- •Patients with a diagnosis or suspicion of keratoconjunctival disease caused by viruses, bacteria, or fungi
- •Patients which presents an allergy to the drug to be tested or to any similar drug such as other corticosteroids
- •History of increased intraocular pressure due to the use of corticosteroids
- •Patients with pathological macular features
- •Diabetics
- •Breastfeeding women
- •Patients with rheumatoid arthritis.
- •Patients treated with Amiodarone
研究组 & 干预措施
Intervention
Difluprednate Ophthalmic Emulsion 0.05%
干预措施: Difluprednate Ophthalmic Emulsion 0.05% (Drug)
Comparator
Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension
干预措施: Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution (Drug)
结局指标
主要结局
Change from baseline corneal thickness between treatments
时间窗: Baseline to visit 3 (96 hours from surgery)
Demonstrate that 0.05% difluprednate ophthalmic nanoemulsion administered 1 drop, 2 times a day, beginning the day before cataract surgery and continuing for the first 14 postoperative days and then 1 drop, once a day for the next 14 days, it does not present an anti-inflammatory efficacy lower than treatment with prednisolone acetate 1% + phenylephrine hydrochloride 0.12% ophthalmic suspension administered 1 drop, 4 times a day starting the day before surgery and continuing during the first 14 post-surgical days and 1 drop , 2 times a day for the next 14 days, for the treatment of postsurgical inflammation, in patients operated on for N2 and N3 cataracts. Difluprednate 0.05% ophthalmic nanoemulsion will not be clinically inferior than Prednisolone acetate 1% + 0.12% phenylephrine hydrochloride ophthalmic suspension, if the difference in corneal thickness obtained with OCT between the baseline day and the post-surgical day it does not differ beyond 17 µm between treatments.
次要结局
- Visual acuity(Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).)
- Equal safety profile of both treatments(Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28))
- Flare and cell on anterior chamber(Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).)
- Intraocular pressure(Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).)
- Corneal endothelial cell count(Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).)
- Corneal Thickness by pachymetry(Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).)
- Retinal Thickness(Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28))