Assessment of the Effects and Tolerability of RD03/2016 (Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v Eye Drops Solution) for the Treatment of Bacterial Conjunctivitis in Adults: a Multicentre, Randomized, Blinded-assessor, Phase II Non Inferiority Study - MIRAKLE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- NTC srl
- 入组人数
- 252
- 试验地点
- 41
- 主要终点
- Proportion of patients with microbiological eradication
研究概览
简要总结
This is a phase II, randomized, parallel-group, blinded-assessor, multicentre study to assess the non-inferiority of RD03/2016 eye drops vs. levofloxacin eye drops alone (1:1) in microbiological eradication in patients with a clinical diagnosis of bacterial conjunctivitis with moderate/severe signs.
详细描述
This study will enroll 252 patients with clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score ≥ 2 for each cardinal sign, i.e., bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge).
Enrolled patients will attend three study visits: baseline (Day 0), On-Therapy (OT; Day 3-4) and final visit (Day 7-9). The duration of the study for each patient will be 7-9 days.
Enrolled patients will undergo the following assessments: anamnesis; ophthalmological examination; swab of the lower conjunctiva for bacteriological examination, and a urine pregnancy test (for women of childbearing potential). Patients will be provided with a study smartphone to take photographs of the affected eye at home. Photographs will be taken by the person (a relative or a caregiver) assisting the patient and uploaded on the server of the study eCRF through eyePRO.net.
Test product (i.e. RD03/2016 - Levofloxacin; Ketorolac Trometamol 0.5+0.5% w/v eye drops solution) is the first fixed dose association between a quinolone antibiotic (i.e. levofloxacin) highly effective on the pathogenic bacteria that most frequently cause eye infections, and a nonsteroidal anti-inflammatory drug (NSAID) (i.e. ketorolac) highly effective in the control of signs and symptoms associated with inflammation.
The dosage proposed for RD03/2016 is one drop 4 times a day for 5 days, lower than that currently approved for levofloxacin alone. In patients with clinical diagnosis of bacterial conjunctivitis and in presence of moderate/severe signs and symptoms requiring an anti-inflammatory treatment for rapid symptomatic improvement, the use of RD03/2016 compared to treatment with levofloxacin alone could lead to a substantial simplification of the therapeutic regimen, without changing the rate of microbiological eradication.
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
- Single (Investigator)
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
- •Ability of patient to consent and provide signed written informed consent
- •Male or female aged ≥ 18 year.
- •Clinical diagnosis of acute bacterial conjunctivitis with moderate/severe signs (score ≥ 2 for each cardinal signs, i.e. bulbar conjunctival injection, palpebral conjunctival injection and conjunctival discharge, in at least one eye), not previously treated with antibiotics, steroids and nonsteroidal anti-inflammatory drugs (NSAIDs).
- •Able and willing to follow study procedures.
- •Availability of a person (a relative or a caregiver) to be trained for the execution of the photographic documentation required by the study and for the use of eyePRO.net.
- •Willing to interrupt the use of contact lenses for the entire duration of the study.
排除标准
- •Any acute ocular clinical disease other than bacterial conjunctivitis.
- •Any ocular surgery (including laser treatment) in the study eye within 30 days prior to study entry.
- •Any ocular (in the study eye) or systemic antimicrobial agents administered concurrently or within 3 days prior to study entry.
- •Any ocular (in the study eye) or systemic steroids or NSAIDs administered concurrently.
- •Pathological conditions or treatments that in the opinion of the Investigator may interfere with the efficacy and/or safety evaluations of the study (e.g. chronic blepharitis, glaucoma, moderate-severe dry eye).
- •Participation in previous clinical studies if less than 5 half-lives of the Investigational Medicinal Product (IMP) used have passed.
- •Hypersensitivity to the products, other quinolones, acetylsalicylic acid and other NSAIDs (due to potential for cross-sensitivity), or their excipients.
- •Contraindications to ocular treatment with levofloxacin and/or ketorolac.
- •Pregnancy or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at baseline visit and practice effective contraceptive measures throughout the study.
研究组 & 干预措施
Test arm
Patients will be randomly assigned (1:1) to one of the two treatment groups
干预措施: RD03/2016 eye drops (Drug)
Standard drug arm
Patients will be randomly assigned (1:1) to one of the two treatment groups
干预措施: Levofloxacin 0.5% eye drops solution (Oftaquix®) (Drug)
结局指标
主要结局
Proportion of patients with microbiological eradication
时间窗: At the Final visit (Day 7-9)
Absence/no growth of pathogenic microorganisms or reduction below pathogenic criteria of opportunistic microorganisms susceptible to levofloxacin identified at baseline, as assessed through bacteriological culture and antibiotic susceptibility testing at the final visit (Day 7-9).
次要结局
- By-pathogen microbiological eradication rate of levofloxacin-susceptible bacteria(At baseline that are eradicated at the final visit (Day 7-9))
- Overall per-patient microbiological eradication rate of bacteria intermediate or resistant to levofloxacin(At the final visit (Day 7-9))
- Overall by-pathogen microbiological eradication rate of bacteria intermediate or resistant to levofloxacin(At baseline that are eradicated at the final visit (Day 7-9))
- Proportion of patients with clinical cure(At Day 3-4 and final visit (Day 7-9))
- Time to clinical cure(Every 12 ± 1 hours from Day 0 to Day 7-9)
- Time to resolution (absence) of bacterial conjunctivitis symptoms(Every 12 ± 1 hours from Day 0 to Day 7-9)