Clinical Study of the Efficacy of the Ophthalmic Solution of Pazufloxacin 0.6% (PRO-157) for the Treatment of Acute Bacterial Conjunctivitis, Compared to the Ophthalmic Solution of Gatifloxacin 0.3%.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 6
- 主要终点
- Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
研究概览
简要总结
Phase III clinical study of non-inferiority, multicenter, double-blind, with comparative group, of parallel groups and randomized. about a ophthalmic topical antibiotic for the treatment of bacterial conjunctivitis.
Goal:To compare the efficacy of the ophthalmic solution of pazufloxacin 0.6%, against the ophthalmic solution of gatifloxacin 0.3%, in the treatment of acute bacterial conjunctivitis.
Hypothesis:the ophthalmic solution PRO-157 is not inferior in the treatment of bacterial conjunctivitis, compared to the ophthalmic solution of gatifloxacin 0.3%, by means of the clinical remission of the disease.
Number of patients:
160 patients, each one will provide an eye for efficacy analysis, divided into 2 groups (80 eyes per group).
详细描述
The study subjects will be recruited from various research centers in western and central Mexico.
Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes.
The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days.
The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico.
The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed.
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)
盲法说明
In addition, the statistical analysis will be carried out in a blinded manner in the case of a partial and final analysis.
The masking will be done using boxes in the primary packaging identical in the two groups and relabelling the bottles of both interventions.
Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the assignment number.
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age ≥ 1 year.
- •Both genders.
- •Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia
排除标准
- •Pregnant women, lactating or planning to become pregnant.
- •Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
- •Participation in another clinical research study ≤ 30 days before the baseline visit.
- •Previous participation in this same study.
- •That they can not comply with their attendance at appointments or with all the requirements of the protocol.
- •Single eye
- •Presence of corneal abrasion or corneal ulceration in the study eye.
- •History Users of contact lenses who are not willing to suspend their use during the study.
- •Users of any formulation with ophthalmic application, including lubricants, that can not, or do not want to suspend it during the study.
- •Antecedents of eye surgery 6 weeks prior to study entry.
- •Viral or allergic conjunctivitis.
- •Active uveitis.
- •Active ulcerative keratitis.
- •Recurrent corneal erosion syndrome
- •Antecedent of hypersensitivity or allergy to fluoroquinolones.
研究组 & 干预措施
PRO-157
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
干预措施: Pazufloxacin (Drug)
Zymar
Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
干预措施: Zymar (Drug)
结局指标
主要结局
Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
时间窗: will be evaluated at the end of the treatment (day 8, final visit)
The ocular secretion will be classified as 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The number will be reported according to the rating granted at final visit.
Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment
时间窗: will be evaluated at the end of the treatment (day 8, final visit)
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. Will be graduated using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
次要结局
- Adverse Events(day 0 to day 17 (visit 0 to security call))
- Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment(will be evaluated at the end of the treatment (day 8, final visit))
- Presence of Bacterial Eradication Compared to Baseline Culture Results(will be evaluated at the end of the treatment (day 8, final visit))
- Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit(will be evaluated at the end of the treatment (day 8, final visit))