A Randomized, Double Blind, Phase II Multicenter Trial to Evaluate the Safety and Efficacy of PRO-157 Ophthalmic Solution in Three Different Dosing Regimen Versus Moxifloxacin Versus Gatifloxacin in Patients With Bacterial Conjunctivitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change From Baseline Bacterial Culture
研究概览
简要总结
A randomized, double blind, phase II multicenter trial with the objective of assess the safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.
Number of participants: 300 eyes, 60 per group.
Criteria for evaluation:
Measurements of effectiveness: Main efficacy criterion It will be determined as effective if there is a reduction in number or species of bacterial flora by comparing the basal culture against the final culture among the five different patient groups.
Reduction or absence of infection with the clinical evaluation through signs and symptoms.
Safety Measurements: it will be determined by visual acuity and adverse events Patients recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken into account at the time of baseline, however the study medication and procedures will be applied and performed in both eyes to protect the healthy eye.
The study is divided into the following evaluation periods:
Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23) for the evaluation of adverse events.
Subjects will be allocated to any of the following regimen dosages:
- PRO-157 1 drop 2 times daily
- PRO-157 1 drop 3 times daily
- PRO-157 1 drop 4 times daily
- Moxifloxacin 1 drop 3 times daily
- Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes before instillation of study drug, during study period.
Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in which each of the variables is described, the ITT population will be constituted by all subjects recruited who have received at least one dose of the study, the PP population will be the subset of ITT composed of all subjects without any major deviation from the protocol and the bivariate analysis will be performed in this group.
Continuous quantitative variables are expressed and presented by measures of central tendency and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal variables are presented by means of frequencies and proportions. The level of significance was an alpha of 0.05 or less.
详细描述
Lagricel Ofteno® is a registered trademark, therefore the use of the same throughout the document can not be translated into the English language.
PRO-157, the acronym is part of an internal code used to record formulations or research projects and the numbers indicate consecutive of the molecule under study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Day 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtained from physician office visit.
- •Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture).
- •Informed Consent signed and dated (consent of the parents for minor patients).
排除标准
- •absence of written informed consent.
- •Women of childbearing age, without contraceptive use (oral contraceptive pill, contraceptive intrauterine device, contraceptive implant, patch or condom).
- •Pregnant or breastfeeding women.
- •Subjects that could not be evaluated partially or totally according to the protocol.
- •Subjects with topical, systemic or intravenous medication with any type of antibiotic on the day of the baseline visit.
- •Subjects with topical, systemic or intravenous medication with any type of medication that interferes decisively with the results of the study.
- •Subjects with a hypersensitivity history to any component or analogues of the formulation product.
- •Positive drug addiction (smoking, alcoholism, marijuana).
- •Subjects with a history of participation in any clinical study in the last 40 days prior to their evaluation.
- •incapacity to give informed consent owing to mental disorder or legal condition.
- •Any major anomaly detected during the clinical examination, tests that could interfere with the performance of the study or with the efficacy and safety evaluations.
研究组 & 干预措施
PRO-157 BID (2 times per day)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
- instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
干预措施: PRO-157 (Drug)
PRO-157 BID (2 times per day)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days
- instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
干预措施: Lagricel Ofteno® (Drug)
PRO-157 TID (3 times per day)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
干预措施: PRO-157 (Drug)
PRO-157 TID (3 times per day)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
干预措施: Lagricel Ofteno® (Drug)
PRO-157 QID (4 times per day)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
干预措施: PRO-157 (Drug)
PRO-157 QID (4 times per day)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
干预措施: Lagricel Ofteno® (Drug)
Moxifloxacin (Vigamox®)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)
干预措施: Vigamox (Drug)
Moxifloxacin (Vigamox®)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days.
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)
干预措施: Lagricel Ofteno® (Drug)
Gatifloxacin (Zymar®)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)
干预措施: Zymar® (Drug)
Gatifloxacin (Zymar®)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
- instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days.
- 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)
干预措施: Lagricel Ofteno® (Drug)
结局指标
主要结局
Change From Baseline Bacterial Culture
时间窗: up to one week
Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species. The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects.
Adverse Events
时间窗: during the intervention period for 7 days, and 15 days after the final visit
Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.
次要结局
- Cases Frequency of Ocular Secretion(Up to one week.)
- Number of Cases of Conjunctival Hyperemia(up to one week)
- Chemosis Frequency(up to one week)
- Eyelid Edema Frequency(Up to one week)
- Frequency of Corneal Epithelial Defects(Up to one week)