A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28
研究概览
简要总结
The primary objectives of this investigation were to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day.
详细描述
This was a multicenter, randomized, parallel group, investigator-masked, non-inferiority study. Approximately 84 subjects were planned to be randomized in a 1:1 ratio.
The primary performance endpoint was the mean change from baseline (CFB) in the study eye at Day 28 in the Ocular surface fluorescein staining score as assessed by the Oxford Scheme.
Following a screening visit (Visit 1) and a 2-week washout with povidone 2% artificial tear (ART), participants were randomized on Day 0 (Visit 2) with follow-up visits on Day 28 ±3 (Visit 4) and Day 90 ±10 (Visit 5). A telephone assessment took place on Day 7 ±1 ('Visit 3') for safety and compliance.
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
- Single (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 of at least 18 and ability to read, understand, and provide written voluntary informed consent on the Ethics Committee approved Informed Consent Form
- •Ability and willingness to comply with all treatment and follow-up and study procedures
- •Use of tear substitutes for at least 2.5 months prior to inclusion, and agreement to use multidose preservative-free ART (Aqualarm® U.P. povidone 2% eye drops in 10 mL bottles) up to 6 times a day for at least 2 weeks immediately prior to randomization
- •Symptom score ≥ 1 for at least 2 out of the 7 following symptoms (rated 0 to 4): sensation of dryness, foreign body, burning, stinging, itching, blurred vision, sensitivity to light
- •At least 1 eye with the following signs of keratoconjunctivitis sicca :
- •Tear break-up time of 10 sec (mean of 3 measurements) at both screening visit and inclusion visit
- •Total ocular surface staining score ≥ 4 and ≤ 9 at both screening visit and inclusion visit. This assessment combines corneal, nasal and temporal bulbar conjunctival fluorescein staining, each graded 0-5 according to the Oxford Scheme
- •A decimal visual acuity with habitual correction equal to or better than 0.1 (Monoyer chart) in both eyes
- •No systemic treatment or who had received stable systemic treatment (unchanged for 1 month or longer)
- •Female subjects had to be into 1 of the following categories:
- •Post-menopausal
- •Surgically sterile
- •Using birth control method throughout the duration of the study
- •Female of childbearing potential needed a negative urine pregnancy test result at screening
排除标准
- •Severe blepharitis
- •Severe ocular dryness accompanied by 1 of the following:
- •Lid abnormality
- •Corneal disease
- •Ocular surface metaplasia
- •Filamentary keratitis
- •Corneal neovascularization
- •Use of contact lenses at inclusion or within 90 days prior to study start
- •History of ocular surgery, including laser surgery, in either eye within 180 days prior to study start
- •History of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
- •History of ocular allergic disease or ocular herpes within 1 year prior to study start
- •History of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
- •Known hypersensitivity or contraindications to any of the ingredients in the test or comparator products or ART
- •Initiation of, or changes to, concomitant medication that could affect dry eye within 30 days prior to Visit 1 (Screening) or with planned initiation or changes of such medications during the study
- •Ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
- •Expected use of ocular therapy during the study
- •Use of topical ocular steroidal or non-steroidal anti-inflammatory medication within 30 days prior to study start
- •Expected use of ocular therapy with immunosuppressants during the study or use of ocular immunosuppressants within 90 days prior to study start
- •Use of occlusion therapy with non-resorbable lacrimal or punctum plugs within 90 days prior to study start or use of resorbable plugs
- •Use or planned use of therapy such as LipiFlow® or BlephEx®
- •Breastfeeding females
- •Participation in any drug or device clinical investigation within 30 days prior to entry into study and/or during the period of study participation
结局指标
主要结局
Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 28
时间窗: Baseline (Day 0), Visit 4 (Day 28)
Mean change from baseline (CFB) in the study eye in Ocular Surface Fluorescein Staining (OSFS) scored according to the Oxford Scheme. The Oxford Scheme is a validated scale consisting of a series of panels labelled A to E in order of increasing severity. Grade 0 corresponds to panel A increasing to Grade 5 corresponding to more than Panel E, with punctate dots representing staining. The 3 regions, cornea, nasal and temporal bulbar conjunctiva are graded separately from 0 (best outcome) to 5 (worst outcome), with the Ocular Surface Fluorescein Score (OSFS) ranging from 0 (best outcome) to 15 (worst outcome). The OSFS is the sum score of the 3 sub-scores (corneal, nasal and temporal regions). The study eye was the eligible eye with the highest OSFS score at baseline, which needed to be ≥4 and ≤9 on the 15-grade Oxford Scheme. If both eyes were eligible and had the same OSFS score, the study eye was the right eye.
次要结局
- Change From Baseline in the Ocular Surface Disease-Quality of Life (OSD-QoL®) at Day 90 (Visit 5)(Baseline (Day 0), Visit 5 (Day 90))
- Change From Baseline in Tear Film Break Up Time (TFBUT) at Day 28 (Visit 4) and at Day 90 (Visit 5)(Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90))
- Change From Baseline in Schirmer Test at Day 28 (Visit 4)(Baseline (Day 0), Visit 4 (Day 28))
- Frequency of Eye Drop Instillation(From Day 0 to Day 90, an average of 3 months)
- Change From Baseline in Ocular Surface Fluorescein Staining Score at Day 90 (Visit 5)(Baseline (Day 0), Visit 5 (Day 90))
- Change From Baseline in Corneal Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)(Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90))
- Change From Baseline in Nasal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)(Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90))
- Change From Baseline in Temporal Conjunctival Fluorescein Staining Score at Day 28 (Visit 4) and at Day 90 (Visit 5)(Baseline (Day 0), Visit 4 (Day 28), Visit 5 (Day 90))
- Change From Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4) and at Day 90 (Visit 5)(Baseline (Day 0), Visit 4 (Day 28) and Visit 5 (Day 90))