STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Efficacy of PRO-118 ophthalmic solution.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
详细描述
A phase II, double-masked, randomized, placebo-controlled, parallel-group and multicenter clinical trial, to evaluate and compared the clinical efficacy and safety of four doses of PRO-118 ophthalmic solution ( PRO-118 0.015% qd, PRO-118 0.015% twice daily , PRO-118 0.020% qd, PRO-118 0.020% twice daily) for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of seasonal or perennial allergic conjunctivitis.
- •Age ≥ 6 years old at screening visit.
- •Male or female patients.
- •Applicable in patients ≥ 18 years old.
- •Patient has signed the Informed Consent Form (ICF) prior to any screening procedures.
- •Applicable in patients with age ≤ 18 years old.
- •Patients Patients'parents or legal guardians signed an Informed Consent Form (ICF).
- •The patients also provided written assent.
排除标准
- •Presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (Atopic keratoconjunctivitis, giant papillary conjunctivitis).
- •Any other ophthalmic medication within seven days prior to randomization.
- •Patient with one blind eye.
- •Visual acuity of 20/40 in any eye.
- •Patients with history of active stage of any other concomitant ocular disease.
- •Contraindications or sensitivity to any component of the study treatments.
- •Contact lens users.
- •Ocular surgery within the past 3 months.
- •Women who were not using an effective means of contraception or who were pregnant or nursing.
- •Participation in any studies of investigational drugs within 90 days previous to the inclusion.
- •Discontinuation criteria:
- •Patients could be discontinued before the completion of the study because of use of prohibited medications, adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
研究组 & 干预措施
Arm C. PRO-118/Placebo 0.015%,0.020%
干预措施: PRO-118 Ophthalmic Solution 0.020 % (Drug)
Arm D. PRO-118/Placebo 0.015%,0.020%
干预措施: PRO-118 Ophthalmic Solution 0.020 % (Drug)
Arm A. PRO-118/Placebo 0.015%,0.020%
干预措施: PRO-118 Ophthalmic Solution 0.015% (Drug)
Arm B. PRO-118/Placebo 0.015%,0.020%
干预措施: PRO-118 Ophthalmic Solution 0.015 % (Drug)
Arm E PRO-118/Placebo 0.015%,0.020%
干预措施: Placebo Ophthalmic Solution (Drug)
结局指标
主要结局
Efficacy of PRO-118 ophthalmic solution.
时间窗: 21 days.
Primary efficacy measure: Evaluation of ocular itching. Secondary efficacy measures: Evaluation of symptoms(redness eye,ocular irritation, foreign body sensation, photophobia and lacrimation) and signs(conjunctival hyperaemia,chemosis, mucous discharge ocular and presence of follicles/papillae).
次要结局
- Safety of PRO-118 Ophthalmic Solution.(21 days.)