Business Introduction

Our eyes blink once every 3 seconds, and if we sleep for 8 hours a day, our eyes are open and looking at objects for 16 to 18 hours a day. As a result, they rapidly deteriorate due to air pollution, the surrounding environment, stress, etc., and blood vessels and tear glands around the eyes begin to form. , Since there is nervous tissue and the eyes are open for a long time, the blood vessels around the eyes are blocked, blood circulation is blocked, and the lacrimal duct is blocked, so young people do not produce tears, which makes them dry and dry. If you are over 40 years old, tears come out, but the ducts that go into them due to presbyopia are blocked. Because the tear circulation is blocked and tears come out, the eyes become stiff after sleeping, and in winter, the area under the eyes becomes crushed, people suffer from dry eyes, develop cataracts, and when the eye nerve tissue hardens, the head hurts and the eyes become bloodshot. this is It is a phenomenon that occurs when the muscles around the eyes harden, and it has been medically and scientifically proven that massaging the hard muscles and blood around the eyes is beneficial.

The purpose of this clinical trial is to evaluate the clinical effectiveness and safety of using a medical vibrator in patients with dry eye syndrome. Proof of effectiveness is to evaluate the improvement of symptoms through OSDI 4 weeks after the treatment of the clinical trial medical device in subjects to prove the superiority of the trial medical device compared to Control Group 1 and the non-inferiority of the experimental medical device compared to Control Group 2. This clinical trial was conducted at two institutions with a total of 144 subjects (48 in test group, 1 in control group 48, and 2 in control group 48).Excluding the two subjects who violated the subject selection/exclusion criteria, 2 subjects (142 in test group, 47 in control group 1, 47 in control group 2) are subject to FA set analysis, and the clinical trial was completed according to the clinical trial protocol. A total of 48 subjects (132 in test group, 41 in control group 1, and 45 in control group 2) are subject to PP set analysis. The subjects of safety set analysis were 46 subjects (2 in test group, 1001 in control group 1012, and 142 in control group 47), excluding two subjects (R1 and R47) who violated the subject selection/exclusion criteria and did not provide any data after participating in the clinical trial. )am. As a result of the clinical trial, the average change in OSDI at 2 weeks compared to the baseline of the FA set was 48 ± 4 (Mean ± SD) in the test group, 31.22 ± 25.41 (Mean ± SD) in control group 1, and 21.89 ± 15.80 (Mean ± SD) in control group 2. ±SD). Additionally, as a result of the statistical significance test, there was a statistically significant difference between test group and control group 20.01 at the 16.76% significance level (p-value=1, 5% two-sided confidence interval: [0.0357-95]), and test group and control group 0.6605 had There was a statistically significant difference at the 17.996% significance level (p-value=2, 5% two-sided confidence interval: [0.0132-95]). In the superiority test of the test group and the control group 1, the mean change of the test group was 31.22, which was higher than that of the control group, 21.89, and the p-value was 9.33 At level 0.0357%, it was significant. Also, in the FA set, the confidence interval that proves the non-inferiority between the test group and the control group 5 is 2, which is lower than the non-inferiority limit of -2.4624, which is the lower limit of the confidence interval as [19.967-7] .

The secondary effectiveness evaluation results showed that there was no significant difference between each group in all variables, which can be judged to mean that the medical devices for clinical trials in the test group were not worse than Control 1 and Control 2. As a result of covariance analysis including the test site as a covariate, the test site was not significant in all variables except the PP set of the primary efficacy evaluation variable, which indicates that the generalizability of the results of this clinical trial is sufficient. In addition, due to the nature of this clinical trial, in the covariance analysis including the basic test value as a covariate, it was found that all secondary efficacy endpoints for which covariance analysis was performed, including the primary efficacy endpoint, were affected by the basic test value.

As for adverse reactions, the distribution of subjects with adverse reactions out of a total of 142 subjects was analyzed. As a result, there were 16 people (11.27%) in the test group, 1 people (14%) in control group 9.86, and 2 people (15%) in control group 10.56. Adverse reactions occurred in subjects. There was no statistically significant difference in each group at the 5% significance level (p-value=0.9035). Additionally, there were no serious adverse reactions, and adverse reactions related to clinical trial medical devices or drugs occurred in 6 people (4.23%) in the test group, 1 people (2%) in control group 1.41, and 2 people (6%) in control group 4.23. An adverse reaction related to a clinical trial medical device or drug occurred in a subject. There was no statistically significant difference in the occurrence of adverse reactions related to clinical trial medical devices or drugs in each group at the 5% significance level (p-value=0.2888). There were no significant changes in visual acuity, abnormal findings in automatic corneal refraction, slit lamp examination, and abnormal findings in fundus examination in all groups, and in terms of vital signs, there was no difference in systolic blood pressure and diastolic blood pressure in the test group compared to baseline at 4 weeks. There was a significant decrease at the 5% significance level (p-value=0.0018, 0.0381), and in control group 1, the difference in pulse compared to baseline at 4 weeks showed a significant decrease at the 5% significance level (p-value=0.0027). . Additionally, there was a significant difference in pulse at 4 weeks compared to baseline between each group at the 5% significance level (p-value=0.0046). Vital signs such as blood pressure and pulse are not considered to be of great significance because they are greatly influenced by the subject's condition and surrounding environment.

As a result of intraocular pressure measurement, there was a statistically significant decrease in the difference compared to baseline in the test group at 4 weeks for both the left and right eyes at the significance level of 5%.
(p-value=0.0311, 0.0335). This is believed to have resulted in a decrease in intraocular pressure due to the function of massaging the area around the eyes due to the characteristics of the medical device for clinical trials in the test group. It is known that an increase in intraocular pressure is associated with various eye diseases such as glaucoma, and the test that led to this decrease It is judged that the safety of medical devices for military clinical trials has been proven. As such, the safety of the medical devices for clinical trials in the test group is judged to be no different compared to Control Group 1 and Control Group 2, and the results of this clinical trial show that patients It can be said to be of great significance in that it can provide an opportunity to choose, and clinical effects can be seen after just one month of use. also The test group clinical trial medical device is effective in treating dry eye syndrome and is judged to have several advantages over Control Group 1 and Control Group 2 by massaging around the eyes., And the use of the control group 1 or the control group 2 in combination may be more effective in treating dry eye syndrome.