PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK IN TREATMENT OF ALLERGIC CONJUNCTIVITIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- Ocular itching
研究概览
简要总结
The present study will be carried out to evaluate the antiallergic efficacy of Bepotastine besilate 1.5% free of preservatives versus standard treatment with 0.2% Olopatadine hydrochloride with 0.1% benzalkonium chloride as preservative in adult patients diagnosed with allergic conjunctivitis.
The antiallergic efficacy will be evaluated by the reduction of ocular signs and symptoms and by the resolution of non-ocular symptoms (rhinorrhea, congestion, and nasal pruritus), as well as the effect of the preservative and its relationship with the cytotoxicity of the ocular surface. Also will evaluate the safety of both products.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old.
- •Clinical diagnosis of allergic conjunctivitis and active allergy with at least 2 points on itching and hyperemia scale.
- •Patients with history of allergic conjunctivitis.
- •Patients who accept no to wear contact lens during the duration of the trial.
- •Patients who accept no to use any other medication by any delivery route.
- •Patients with intraocular pressure controlled (less than 18 mmhg)
排除标准
- •Patients who have undergone refractive surgery within the 6 months prior to the start of the study
- •Patient with ocular or systemic active diseases
- •Patients who are participating in another trial
- •Patients who have used eye medication in the last 15 days and/or who have received anti-inflammatory drugs (corticosteroids and/or NSAIDs) and/or antihistamines by mouth or intravenous.
- •Patients hypersensitive to any component of the products: Bepotastine besilate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide, Olopatadine hydrochloride, benzalkonium chloride, dibasic sodium phosphate, hydrochloric acid, edetate disodium or povidone K29 /
- •Women who are breastfeeding and pregnant.
研究组 & 干预措施
Bepotastine besilate 1,5% preservative free
Bepotastine besilate 1,5% in preservative-free bottle, administered once a day during the morning.
干预措施: Bepotastine Besilate 1.5% PF (Drug)
Olopatadine hydrochloride 0,2% with BAK
Olopatadine hydrochloride 0,2% with BAK as preservative, administered once a day during the morning.
干预措施: Olopatadine Hydrochloride 0.2% BAK (Drug)
结局指标
主要结局
Ocular itching
时间窗: Baseline, Day 15, Day 30, Day 45, Day 60
Change of 1 point of scale 0-3 (none, mild, moderate, severe) in at least 1 visit between gruops.
次要结局
- Eye burning(Baseline, Day 15, Day 30, Day 45, Day 60)
- Eye lacrimation(Baseline, Day 15, Day 30, Day 45, Day 60)
- Foreign body sensation(Baseline, Day 15, Day 30, Day 45, Day 60)
- Rhinorrhea(Baseline, Day 15, Day 30, Day 45, Day 60)
- Nasal congestion(Baseline, Day 15, Day 30, Day 45, Day 60)
- Nasal pruritus(Baseline, Day 15, Day 30, Day 45, Day 60)
- Visual Acuity(Baseline and Day 60)
- Meniscus height(Baseline, Day 15, Day 30, Day 45, Day 60)
- Conjunctival hyperemia(Baseline, Day 15, Day 30, Day 45, Day 60)
- Conjuctival impression cytology(Baseline, Day 30, Day 60)
- Eyelid swelling(Baseline, Day 15, Day 30, Day 45, Day 60)
- Chemosis(Baseline, Day 15, Day 30, Day 45, Day 60)
- Eye discharge(Baseline, Day 15, Day 30, Day 45, Day 60)
- Adverse reactions(Baseline, Day 15, Day 30, Day 45, Day 60.)