NCT01791426撤回不适用
A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Combined Ocular Surface Staining Score
研究概览
简要总结
The objective of this investigation is to show that the performance of Artelac Rebalance eye drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment administered 3 to 5 times per day.
详细描述
Artelac Rebalance and Vismed are in compliance with European Directives (CE marked) products in the European Union (EU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use preservative-free ART (Artelac® UNO CL hypromellose 0.32% w/v eye drops, single dose unit) up to 6 times a day for at least 2 weeks immediately prior to randomization
- •Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca at 2 consecutive visits (Visit 1[Screening] and Visit 2 [Randomization])
- •Schirmer test without anesthesia of ≤ 9 mm/5min
- •Tear break-up time of ≤ 10sec (mean of 3 measurements)
- •Total ocular surface staining score ≥ 4 and ≤
- •This assessment combines corneal fluorescein staining and nasal and temporal bulbar conjunctival lissamine green staining, each graded 0-5 according to the Oxford Scheme
- •Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Snellen E chart) in both eyes
- •Subjects who are receiving stable systemic treatment (unchanged for 1 month or longer)
排除标准
- •Subjects with moderate or severe blepharitis
- •Subjects who have severe ocular dryness accompanied by 1 of the following:
- •Lid abnormality (except mild blepharitis)
- •Corneal disease
- •Ocular surface metaplasia
- •Filamentary keratitis
- •Corneal neovascularization
- •Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start
- •Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start
- •Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start
- •Subjects with a history of ocular allergic disease or ocular herpes within
- •1 year prior to study start
- •Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis
- •Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products
- •Subjects with planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of Visit 1 (Screening) or during the study
- •Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start
- •Subjects expected to receive ocular therapy during the study
- •Subjects treated with topical ocular steroidal or non-steroidal anti- inflammatory medication within 30 days prior to study start
- •Subjects expected to receive ocular therapy with immunosuppressants (eg, cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start
- •Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start
结局指标
主要结局
Combined Ocular Surface Staining Score
时间窗: Mean change from baseline (CFB) to visit 4 (day 28)
Total combined ocular surface staining grade of 0-15 combining corneal fluorescein staining score, nasal and temporal bulbar conjunctiva lissamine green staining score (each graded 0-5 on the Oxford Scheme) in the study eye.
次要结局
- Temporal Conjunctival Lissamine Green Staining(Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90))
- Combined Ocular Surface Staining Score(Mean CFB to visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90))
- Nasal Conjunctival Lissamine Green Staining(Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90))
- Tear Film Break-up Time(Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90))
- Corneal Fluorescein Staining Score(Mean CFB at each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90))
- Study Drop Sensation(Each follow-up visit: visit 3 (Day 7) visit 4 (Day 28) and visit 5 (Day 90))
研究者
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