Randomized, Double-Masked, Vehicle-controlled Phase III Trial on the Safety/Efficacy of FML® 0.1% in the Treatment of the Inflammatory Exacerbation Provoked by Exposure to an Adverse Controlled Environment in Patients With Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Symptom Assessment in Dry Eye (SANDE) I and II questionnaire
研究概览
简要总结
Hypothesis: Fluorometholone (FML) 0.1% eyedrops topically applied 4 times a day for 22 days is more efficient than artificial tears (Liquifilm) in dry eye disease (DED) and ameliorates the worsening of the disease after exposure to an adverse controlled environment.
详细描述
There will be 4 visits in 3 different days:
Visit 1 (V1). Inclusion in normalized controlled environment (NCE)
Visit 2 (V2). 21 days post-treatment. Data collected in NCE
Visit 3 (V3). 21 days post-treatment. Data collected in adverse controlled environment (ACE)
Visit 4 (V4). 22 days post-treatment. Recovery visit in ACE. Data collected in NCE
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
- •Age > 18 years
- •Signed informed consent
- •Subjects refer worsening in their pathologies when exposed to adverse environmental conditions in their daily life
- •Fluorescein corneal staining ≥ 1in Oxford Scale
- •Ocular surface disease index (OSDI) test > 12
- •Tear breakup Time (TBT) ≤ 7 seconds in both eyes
- •Schirmer test without anesthesia ≤ 10 mm in 5 minutes in both eyes
- •Any concomitant medication that may affect dry eye syndrome, ocular surface or vision, must have started at least 3 months before screening visit, and there are no changes in dose expected during the study duration.
- •Best corrected visual acuity at least 0.1 logMar at 6 meters with both eyes
- •Current use of ophthalmic artificial tears at study inclusion.
- •Signed informed consent
- •Signed data protection consent
排除标准
- •Sensitivity or known intolerance to any of the products used in the study
- •Previous severe ocular inflammation or infections in the 6 previous months to study inclusion
- •Any ocular pathology other than dry eye syndrome or atopic keratoconjunctivitis
- •Any ocular surgery or trauma that may affect corneal sensitivity and / or normal tear distribution (refractive or cataract surgery) in the 6 previous months or any ocular or systemic surgery planned during the study duration that may affect the study as assessed by principal investigator.
- •Use of contact lenses in the 3 previous months to study inclusion
- •Use of any topical medication for pathologies other than dry eye syndrome.
- •Any ocular topical treatment for dry eye syndrome with corticosteroids or non steroid anti-inflammatory drugs must have stopped 1 month before study inclusion. Any treatment with topical cyclosporin must have been stopped 3 months before study inclusion.
- •Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren Syndrome)
- •Start, discontinuation or dose change during the study of antihistaminic, cholinergic agents, beta blockers, antidepressants or any other systemic medications with potential effect over tear film.
- •Start of any systemic treatment that may affect dry eye syndrome, vision, ocular surface or intraocular pressure during the 3 previous months to study inclusion.
- •Surgical / non surgical tear point occlusion in the 3 previous months to study inclusion or prevision during study duration for this procedure.
- •Cup / disc ratio > 0.6
- •History of intraocular pressure > 22 mm Hg within 2 months previous to study inclusion
- •Pregnancy or breastfeeding women
- •Inclusion in another research study in the previous 30 days to study inclusion
研究组 & 干预措施
FML 0.1% eyedrops
FML (fluorometholone) 0.1% eyedrops 4 times a day in both eyes for 22 days
干预措施: FML 0.1% eyedrops (Drug)
Liquifilm artificial tears eyedrops
Topical application 4 times a day in both eyes for 22 days
干预措施: Liquifilm artificial tears eyedrops (Drug)
结局指标
主要结局
Symptom Assessment in Dry Eye (SANDE) I and II questionnaire
时间窗: 22 days
Evidence of statistically significant changes in the number of subjects with a reduction ≥ 2 points in SANDE score between pre and post adverse condition exposure in ACE (V2 vs V3) and between post adverse condition exposure and recovery visit (V3 vs V4).
Fluorescein corneal staining
时间窗: 22 days
Evidence of statistically significant changes in the number of subjects with an increase ≥ 1 point in fluorescein corneal staining between pre and post adverse condition exposure in ACE (V2 vs V3) and between post adverse condition exposure in ACE and recovery visit (V3 vs V4).
次要结局
- Adverse events during the trial(22 days)
- Biomicroscopy findings at slit lamp examination(22 days)
- Intraocular pressure (IOP) and fundus examination(22 days)
- Other Efficacy Measures(22 days)
- Tear inflammatory molecule levels(22 days)
- Best corrected visual acuity(22 days)