CTRI/2010/091/001136已完成3 期
A Comparative, Randomized, Single blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Gatifloxacin 0.3 % + Difluprednate 0.05 % eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Slit Lamp Biomicroscopic Examination
研究概览
简要总结
This study is a Comparative, Randomized, single blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Gatifloxacin 0.3 % + Difluprednate 0.05 % eye drops Vs. Gatifloxacin 0.3% + Dexamethasone 0.1% eye drops in 100 patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists. Date of first enrollment will be 23 August 2010.
The primary outcome measures will be Slit Lamp Biomicroscopic Examination at day 0, Day 3, Day 5 and Day 7. The secondary outcome measures will be Conjunctival hyperaemia, Corneal and lid oedema, Ocular Infection, pain, photophobia and tearing will be assessed and observation will be graded as: 0 = Nil, 1 = Mild, 2 = Moderate, 3= Severe at day 0, Day 3, Day 5 and Day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with inflammatory ocular conditions where bacterial infection or a risk of bacterial ocular infection exists.
- •2.Patients showing an anterior chamber cell score of not less than 2 at a day after surgery.
- •3.Written informed consent to participate to the trial.
排除标准
- •1.Patients < 18 & > 60 years.2.Patients who took systemic administration of corticosteroids or immunosuppressive agents in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks were excluded.
- •3.Patients who took systemic administration of non-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 3 days before instillation of the investigational drugs; 4.Patients who instilled of corticosteroids, no-steroidal antiinflammatory agents or antiinflammatory enzyme preparations within 24 hours before the pre-instillation observation (a day after surgery); 5.Patients who underwent perioperative and/or postoperative intravitreous injection of corticosteroids; 6.Patients who underwent sub-conjunctival injection7.Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations; 8.Patients who underwent gas tamponade at the surgery; 9.Patients with endogenous uveitis; 10.Patients having corneal epithelial detachment or corneal ulcer in the target eye; 11.Patients who are suspected of having viral, bacterial or mycotic keratoconjunctival disorders in the target or opposite eye; 12.Patients with glaucoma or ocular hypertension, or those with past history of IOP increased due to instillation of corticosteroids, or those whose IOP has been controlled by use of ophthalmic antihypertensive agents; 13.Patients showing IOP not less than 25 mmHg a day after surgery; 14.Patients who have allergy to corticosteroid drugs; 15.Patients who are required to wear contact lens during the study period; 16.Patients who are scheduled to undergo surgery of the opposite eye during the study period; 17.Patients who are pregnant or may be pregnant or lactating; 18.Patients who have participated in other clinical studies within 3 months.
结局指标
主要结局
Slit Lamp Biomicroscopic Examination
时间窗: Day 0, Day 3, Day 5 and Day 7.
次要结局
- Conjunctival hyperaemia, Corneal and lid oedema, Ocular Infection, pain, photophobia and tearing will be assessed and observation will be graded as 0 Nil, 1 Mild, 2 Moderate, 3 Severe.(Day 0, Day3, Day 5 and Day 7.)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
3 期
A clinical Trial in patients with Bacterial conjunctivitis. Clinical trial is to study efficacy, safety and tolerability of Besifloxacin ophthalmic suspension in comparison to Moxifloxacin ophthalmic solution (reference product).CTRI/2010/091/000279Ajanta Pharma Ltd200
已完成
3 期
A clinical Trial in patients with Tinea pedis and Tinea cruris. Clinical trial is to study efficacy, safety and tolerability of Naftifine Hydrochloride 1% cream in comparison to Terbinafine Hydrochloride 1% cream (reference product).CTRI/2009/091/001025Ajanta Pharma Limited200
已完成
不适用
Evaluation of the Efficacy and Safety of DM934 Versus Théalose on Eye DrynessDry EyeNCT06245421Horus Pharma85
已完成
不适用
Efficacy of Moxibustion Therapy With or Without Smoke for Knee OsteoarthritisPainNCT02772055Chengdu University of Traditional Chinese Medicine138
已完成
不适用
Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp PsoriasisScalp PsoriasisNCT04801433Xijing Hospital240