THE OCULAR TOLERABILITY OF A NEW OPHTHALMIC DRUG-DELIVERY SYSTEM (NODS)
THE OCULAR TOLERABILITY OF A NEW OPHTHALMIC DRUG-DELIVERY SYSTEM (NODS)
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DOI：
10.1007/bf00919405
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发表时间：
1994-01-01
影响因子：
1.6
通讯作者：
KRIEGLSTEIN, GK
中科院分区：
文献类型：
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作者：
DIESTELHORST, M;KRIEGLSTEIN, GK
在一项开放标签、两阶段交叉研究中，我们比较了NODS与Isopto-Naturale（R）滴眼液的眼部耐受性。要求30名健康志愿者使用视觉模拟量表（100 =无眼部不适，0 =重度眼部不适）对他们正在使用的施用系统进行眼部不适评分。此外，每例受试者必须在研究前、第7天、第14天和第21天回答一份问卷并接受全面眼科对照。每个施用形式必须每天仅施用一次至一只眼睛，持续7天，随后是1周的洗脱期。然后改变申请表的类型，再次仅对一只眼睛连续7天进行申请，然后进行最终眼科检查。在研究第7天和第21天记录平均刺激评分。志愿者无眼部疾病史，无眼部急性病理学，无接触镜，在研究前最后四周内或研究期间无条件性角膜异物，无局部治疗，无全身治疗，无糖尿病，无妊娠。获得知情同意。在第1天，以随机顺序向每名志愿者提供两份申请表中的一份。29名志愿者完成了方案（16名男性，13名女性）;平均年龄：26岁（范围20-32岁）。NODS的平均刺激评分：35（2-81）; Isopto-Naturale（R）的平均刺激评分：80.4（45.5-99）。平均刺激评分的差异（NODS与Isopto-Naturale（R））：46.7（3.3-82.1）（p < 0.01）。研究结果表明，在健康志愿者中，与常规滴眼液相比，NODS的眼部不适耐受性较差。然而，应考虑应用不含防腐剂的药物的机会和增加新途径（NODS）的生物利用度的可能性，以及NODS应用任何类型药物后患者全身副作用的风险按比例降低。
In an open label, two period cross-over study we compared the ocular tolerability of NODS vs. Isopto-Naturale(R) eye drops. Thirty healthy volunteers were asked to rate the application system they were using for ocular discomfort, utilizing a visual analog scale in which 100 = no ocular discomfort and 0 = severe ocular discomfort. In addition each subject had to answer a questionaire and underwent a full ophthalmic control before, at day 7, at day 14 and at day 21 of the study. Each application form had to be applied to one eye only once a day for 7 days, followed by a washout period of 1 week. The type of application form was then changed and again had to be applied to one eye only for 7 consecutive days, followed by a final ophthalmic examination. The mean irritation score was recorded at day 7 and at day 21 of the study. Volunteers had no history of eye disease, no acute pathology of the eye, no contact lenses, no conditional foreign body of the cornea within the last four weeks prior to the study or within the study, no local therapy, no systemic therapy, no diabetes, no pregnancy. Informed consent was obtained. At day 1 one of the two application forms was given to each volunteer in a randomized order. 29 volunteers finished the protocol (16 male, 13 female); mean age: 26 years (range 20-32 years). The mean irritation score of NODS: 35 (2-81); the mean irritation score of Isopto-Naturale(R): 80.4(45.5-99). The difference of mean irritation score (NODS vs. Isopto-Naturale(R)): 46.7 (3.3-82.1) (p < 0.01). The results of the study indicate that in healthy volunteers NODS are not as well tolerated as conventional eye drops when compared for ocular discomfort. However, the chance of applying drugs without preservatives and the possibility of increasing the rate of bioavailability from the new route (NODS) as well as the proportionally reduced risk to the patient of systemic side effects after NODS application of any type of drugs should be taken into consideration.