Assessment of Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Subjects While Wearing Contact Lenses and Before Insertion of Contact Lenses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Descriptive evaluation of ocular discomfort as assessed by the subjects
研究概览
简要总结
The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found.
Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES. We have recently shown in a phase I trial that single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy subjects.
However, no data is yet available about safety and tolerability of chitosan-N-acetylcysteine in subjects wearing contact lenses. This is of special interest because the tear film is critical to successful contact lens wear. Disturbances of the quantity or quality of the tear film results in intolerance of contact lens wear and possible damage to the ocular surface. This trial seeks to investigate the local tolerability and possible ocular discomfort of chitosan-N-acetylcysteine eye drops after repeated instillation .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Regular contact lens wear since 3 years minimum
- •Daily wearing time of the contact lens of 8 hours or more
- •Good tolerability of the contact lenses without ocular discomfort or local signs of chemosis, conjunctival redness or other signs of intolerability as judged by the investigator.
- •Subject willing to continue contact lens use for the study period
- •Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings except ametropia
排除标准
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Use of colored contact lenses
- •Abuse of alcoholic beverages or other drugs
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Pregnancy
研究组 & 干预措施
12 subjects wearing soft contact lenses
The medical test device will be administered with the contact lenses inserted
干预措施: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) (Device)
12 subjects wearing soft contact lenses
The medical test device will be administered with the contact lenses inserted
干预措施: Physiological saline solution (Other)
12 subjects wearing rigid contact lenses
The medical test device will be administered with the contact lenses inserted
干预措施: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) (Device)
12 subjects wearing rigid contact lenses
The medical test device will be administered with the contact lenses inserted
干预措施: Physiological saline solution (Other)
12 subjects with soft contact lenses
The medical test device will be administered before insertion of the contact lenses
干预措施: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) (Device)
12 subjects with soft contact lenses
The medical test device will be administered before insertion of the contact lenses
干预措施: Physiological saline solution (Other)
12 subjects with rigid contact lenses
The medical test device will be administered before insertion of the contact lenses
干预措施: Chitosan-N-acetylcysteine eye drops (concentration of 0.1%) (Device)
12 subjects with rigid contact lenses
The medical test device will be administered before insertion of the contact lenses
干预措施: Physiological saline solution (Other)
结局指标
主要结局
Descriptive evaluation of ocular discomfort as assessed by the subjects
时间窗: on 5 consecutive days before and after instillation of the eye drops
次要结局
- Number of subjects experiencing adverse reactions(on 5 consecutive study days)
- Number of subjects with significant increase of redness(on 5 consecutive study days)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna