A comparative, randomized, open label clinical study to assess the efficacy and safety of topical prednisolone acetate 1%, dexamethasone 0.1%, loteprednol etabonate 0.5% and difluprednate 0.05% eye drops in postoperative ocular inflammation following cataract surgery.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Efficacy parameters:
研究概览
简要总结
This study is a randomized, open label, parallel group, single centered, trial comparing the efficacy and safety of prednisolone acetate 1%, loteprednol etabonate 0.5%, dexamethasone 0.1% and difluprednate 0.05% eye drops in post-operative ocular inflammation following cataract surgery for six weeks in 140 patients randomized into 4 groups at department of ophthalmology, KIMS Hospital, VV Puram, Bangalore 560004, India. The primary outcome measures will be **Efficacy parameters :**Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN), Ocular pain assessed by Visual Analogue Scale (VAS).
at six weeks.
The secondary outcome measures will be
**Safety and tolerability parameters :**Intraocular Pressure measured with applanation tonometry, Adverse drug event monitoring.
at six weeks.
Even though there are many studies which have established the efficacy of the commonly used topical corticosteroids, there have been few systematic studies conducted to assess the efficacy and safety of these drugs in postoperative ocular inflammation following cataract surgery in Indian population. Hence, this present study is proposed to be taken up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with senile cataract with an indication for cataract extraction.
- •2.Subjects willing to give informed consent and be available for regular follow up.
排除标准
- •1.Subjects with congenital and traumatic cataract.
- •2.Subjects with recurrent infectious and/or inflammatory eye diseases.
- •3.Subjects with uncontrolled diabetes or associated with complications.
- •4.Subjects with history of auto-immune diseases.
- •5.Subjects who are immunocompromised or having tuberculosis, human immunodeficiency virus (HIV) infection.
- •6.Subjects who develop intra-operative complications during surgery.
- •7.Subjects with history of hypersensitivity to study drugs.
- •8.Subjects with history of steroid use 14 days prior to surgery.
- •9.Subjects with active ocular and/or ENT infections.
- •10.Subjects with uncontrolled glaucoma.
结局指标
主要结局
Efficacy parameters:
时间窗: 6 weeks.
2.Ocular pain assessed by Visual Analogue Scale (VAS).
时间窗: 6 weeks.
1.Anterior chamber cell and flare grading as per standardization of uveitis nomenclature (SUN).
时间窗: 6 weeks.
次要结局
- Safety and tolerability parameters:(1.Intraocular Pressure measured with tonometry.)