Combination Treatment of 5% Natamycin and 1% Voriconazole in Fungal Keratitis: a Prospective Randomized Double Masked Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Success or failure
研究概览
简要总结
OBJECTIVE To evaluate the efficacy and safety of the concurrent treatment of 5% Natamycin and 1% Voriconazole in patients affected by fungal keratitis METHODS AND MATERIALS STUDY POPULATION Patients with smear and or culture proven fungal keratitis presenting to our Instituts, were eligible for enrollment.
STUDY DESIGN Prospective double masked randomized clinical trial.
详细描述
PROTOCOL FOR SUBMISSION AND APPROVAL OF RESEARCH PROJECT
TITLE:
Combination treatment of 5% Natamycin and 1% Voriconazole in fungal keratitis: a Prospective Randomized double masked clinical trial STUDY LOCATION LV Prasad Eye Institute, GMR Varalakshmi Campus, Visakhapatnam, Andhra Pradesh, India INVESTIGATORS Dr Merle Fernandes Consultant, Cornea and Anterior Segment Service LV Prasad Eye Institute, GMR Varalakshmi Campus Visakhapatnam, Andhra Pradesh, India Dr Antonio Di Zazzo Fellow, Cornea and Anterior Segment Service LV Prasad Eye Institute, GMR Varalakshmi Campus Visakhapatnam, Andhra Pradesh, India
Dr J V Raghava Consultant, Cornea and Anterior Segment Service LV Prasad Eye Institute, GMR Varalakshmi Campus Visakhapatnam, Andhra Pradesh, India
Dr Sayali Sane Fellow, Cornea and Anterior Segment Service LV Prasad Eye Institute, GMR Varalakshmi Campus Visakhapatnam, Andhra Pradesh, India
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects > 18 yrs of age Willing to give appropriate informed consent Presence of corneal ulcer measuring > 2mm in vertical and horizontal dimensions at presentation (epithelial defect and signs of stromal inflammation) Microbiologic evidence of fungus on smear and or culture media Willing to return for all the follow up visits
排除标准
- •Patients not willing to give consent Patients unable to cooperate for the procedure Patient with impending, or actual perforation or bilateral corneal ulcer or scleral involvement History of previous ocular surgery Evidence of bacterial, parasitic or viral infection or co-infection Previous corneal scar Known allergy to the study medication (drug or preservative) Pregnant or nursing females Immunocompromised patients
研究组 & 干预措施
group 1
Once the patient is randomized to either of the 2 groups using computer-generated randomization blocks, the hospital pharmacist would provide the appropriate medications. The treating ophthalmologist, microbiologist and patients will be masked to the drug by using similar vials. The experimental group (Group 1) will receive 1% voriconazole eye drop (Aurolab, Madurai, India) + 5% Natamycin ophthalmic suspension eye drop hourly (USP 5% Natamet, M.J. Pharmaceuticals, Mumbai, India).
The subjects will be hospitalized for at least 4 days with medications given by the ward nurse.
Patients will be followed up every week after being discharged until complete resolution is noted.
干预措施: Group 1 Natamycin 5% Suspension + voriconazole 1% eye drops; Group 2 Natamycin 5% Suspension + Vehicle eye drops (Drug)
group 2
Once the patient is randomized to either of the 2 groups using computer-generated randomization blocks, the hospital pharmacist would provide the appropriate medications. The treating ophthalmologist, microbiologist and patients will be masked to the drug by using similar vials. The placebo group (Group 2) will receive Vehicle eye drops + 5% Natamycin ophthalmic suspension every hour (USP 5% Natamet, M.J. Pharmaceuticals, Mumbai, India).
The subjects will be hospitalized for at least 4 days with medications given by the ward nurse.
Patients will be followed up every week after being discharged until complete resolution is noted.
干预措施: Group 1 Natamycin 5% Suspension + voriconazole 1% eye drops; Group 2 Natamycin 5% Suspension + Vehicle eye drops (Drug)
结局指标
主要结局
Success or failure
时间窗: 8 weeks
Primary End point: Complete success: Complete resolution of the infiltrate with formation of a scar on medical treatment alone Partial success: Complete resolution of the infiltrate on medical treatment and use of cyanoacrylate glue and bandage contact lens Failure: Worsening of the ulcer necessitating therapeutic penetrating keratoplasty or evisceration
次要结局
- Best-corrected visual acuity(8 weeks)
研究者
Charitha
MS
L.V. Prasad Eye Institute