Efficacy and Safety of PRO-155 (Zebesten Ofteno®) on Inflammation of the Conjunctival Surface in Subjects With Grade I-III Pterygium vs Placebo.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 3
- 主要终点
- Breakup Time (BUT)
研究概览
简要总结
Title of the study Efficacy and safety of PRO-155 (Zebesten ofteno®) on inflammation of the conjunctival surface in subjects with grade I-III pterygium vs placebo.
Hypothesis H0. The Zebesten® ophthalmic solution (bromfenac 0.09%) is less effective and safe than placebo in reducing conjunctival hyperemia in subjects with grade I-III pterygium.
H1 The Zebesten® ophthalmic solution (bromfenac 0.09%) is more effective and safe than placebo in reducing conjunctival hyperemia in subjects with grade I-III pterygium.
Objective
To evaluate the efficacy and safety of PRO-155 (bromfenac 009%) ophthalmic solution in the treatment of conjunctival hyperemia and ocular surface inflammation in a clinical model of pterygium grade I to III.
详细描述
Variables to be evaluated Visual ability Intraocular pressure. Ocular surface Exploration of the previous segment. Exploration of the posterior segment. Lacrimal rupture time. Corneal de-epithelialization Conjunctival de-epithelialization Adverse events.
PHARMACOLOGICAL INTERVENTION
The pharmacological intervention will consist of the instillation of the ophthalmological solution in the conjunctival cul-de-sac, during the waking period, to any of the following study groups:
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Group 1:
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Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival sac fund (the following application scheme is suggested: start: 7:00 ± 1 hours, continuation: 15:00 ± 1 hour and term: at 19:00 ± 1 hours) for 20 days
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Pro-155 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac (the following application scheme is recommended: start: 7:15 ± 1 hours and term: at 19:15 ± 1 hours) during 20 days
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Group 2:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The double-blind study is a procedure in which the subject and the principal investigator do not know which of the intervention groups was assigned to the subject of the study. To achieve the blinding of the drug, both the investigational drug and the placebo, will be packed in the same bottle, containing the same legends on the label. The blinding codes are protected by a person outside the study designated by the sponsor. The codes are also available in the research center (fully sealed), so that they can be consulted by the Investigator in the event that the subject presents a serious adverse event, prior authorization of the study sponsor, as well as strict continuous blindness during the analysis of data.
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
- •Age of 18 to 90 years.
- •Both genders.
- •Clinical diagnosis of grade I to III pterygium (temporal, nasal, or bitemporal).
- •Possibility of going to the revisions when indicated.
排除标准
- •Subjects with topical or systemic medication that interfere decisively in the results of the study; such as topical immunomodulators, NSAIDs, antihistamines, corticosteroids, artificial tears with conservative, vasoconstrictors etc.
- •Subjects (female) with active sexual life who do not use a contraceptive method.
- •Subjects of the female sex in a pregnant state or who are breastfeeding.
- •Subjects of the female sex with pregnancy test in positive urine.
- •Positive substance abuse
- •Subjects who have participated in any clinical research study in the last 40 days.
- •Subjects legally or mentally incapacitated to give their informed consent for their participation in this study.
- •Subjects that can not comply with the appointments or with all the requirements of the Protocol.
研究组 & 干预措施
PRO-155
Pro-155: 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac for 20 days
干预措施: PRO-155 (Drug)
Placebo
Placebo 1 drop 2 times a day in the period of vigil in the conjunctival cul-de-sac
干预措施: Placebo (Other)
结局指标
主要结局
Breakup Time (BUT)
时间窗: will be evaluated at the end of the treatment at the final visit (day 21)
breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Conjunctival Hyperemia (CH)
时间窗: will be evaluated at the end of the treatment at the final visit (day 21)
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
次要结局
- Number of Eyes With Chemosis(will be evaluated at the end of the treatment at the final visit (day 21))
- Epithelial Defects (ED) Green Lissamine(will be evaluated at the end of the treatment at the final visit (day 21))
- Number of Eyes With Foreign Body Sensation (FBS)(will be evaluated at the end of the treatment at the final visit (day 21))
- Epithelial Defects (ED) Fluorescein Stain(will be evaluated at the end of the treatment at the final visit (day 21))
- Intraocular Pressure (IOP)(will be evaluated at the end of the treatment at the final visit (day 21))
- Presence of Adverse Events (EAS)(will be evaluated at the end of the treatment at the final visit (day 36))
- Visual Capacity(will be evaluated at the end of the treatment at the final visit (day 21))