A Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI©) Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®
详细描述
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient.
A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment
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
- •Mild to moderate dry eye patients based on the Report of International Dry Eye Workshop (DEWS)
- •OSDI score between 12 and 45
- •Provided informed consent
排除标准
- •Patients with one blind eye
- •Visual acuity of 20/100 or worst in any eye
- •Patients with any active ocular disease that would interfere with study interpretation
- •Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol
- •Patients with history of hypersensitivity or contraindication for any drug used in the study
- •Contact lens users
- •Pregnant patients, at risk of pregnancy or breastfeeding
- •Patients without birth control treatment
- •Patients who had participated in any clinical trial in the last 90 days
- •Legal or mentally disabled patients who could not give informed consent
- •Patients who do not provide informed consent
研究组 & 干预措施
PRO-148
PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution
doses: 1 drop in each eye, quarter in day
干预措施: PRO-148 (Drug)
Systane®
Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar
doses: 1 drop in each eye, quarter in day
干预措施: Systane (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI©) Questionnaire
时间窗: Day 60
Ocular Surface Disease Index (OSDI©) questionnaire , consists of 12 questions divided in 3 groups, Each question has a value that can go from 0 to 4 points according to the severity of the case: 0.None of the time, 1. Some of the time, 2.Half of the time, 3.most of the time and 4 all of the time. The points of all the questions will be used in the following formula for converted to a score of 0-100 : (sum of scores) x 25 / (# of questions answered), where 0 represents normality or non-symptomatology and 100 the most severe case. Will be used to measure the symptoms of dry eye disease by obtaining baseline data and comparing them against the last visit.
次要结局
- Schirmer Test(Day 60)
- Tear Film Break up Time(Day 60)