To evaluate the correlation between changes of subjective symptoms and objective signs before and after 3% diquafosol sodium eye drops treatment in patients with dry eyes.

This was a multi-center, prospective large scale phase Ⅳ clinical trial. A total of 2660 patients (2660 eyes) with dry eye were included in Beijing Tongren Eye Center, Beijing Tongren Hospital affiliated with Capital Medical University and others 30 ophthalmology clinics nationwide from May 2019 to June 2021. Among them, there were 680 males (680 eyes) and 1980 females (1980 eyes), aged 21 to 69 years with an average age of (44.0±15.3) years. Patients were treated with 3% diquafosol sodium eye drops 6 times a day alone for 30 days. The objective signs, including slit-lamp microscopic examination, tear film breakup time (BUT), corneal fluorescein staining (CFS), Schirmer Ⅰ test (SⅠt) and subjective symptoms, including dry eye-related quality-of-life score (DEQS), were perfomed before and after treatment for 14 days and 30 days. The DEQS total score and DEQS total perception followed a normal distribution and were expressed as ±s, compared by independent sample t-test between two groups, and by one-way analysis of variance among multiple groups. When the difference was statistically significant, SNK method was further used for pairwise comparison. Pearson correlation analysis was used to analyze the correlation between changes of subjective symptoms and objective signs after treatment.

After treatment for 14 days and 30 days, the changes of DEQS total score and DEQS total perception in BUT>5 s subgroup were(-17.57±17.29)scores, (-20.15±17.39)scores, (-1.00±0.89)scores, (-1.00±0.89)scores, respectively; the changes in BUT≤5 s subgroup were (-12.36±15.67)scores, (-14.38±16.07)scores, (-0.70±0.82)scores, (-0.70±0.80)scores, respectively. There were significant differences in changes of DEQS total score between two groups (t=-2.87, -3.34; P<0.05). After treatment for 14 days and 30 days, the changes of DEQS total perception in SⅠt>10 mm, 5 mm<SⅠt≤10 mm, SⅠt≤5 mm subgroup were (-0.60±0.72)scores, (-0.80±0.82)scores, (-0.80±0.77)scores, (-1.00±0.86)scores, (-0.80±0.87)scores, (-1.10±0.93)scores, respectively; the changes of DEQS total score were (-9.83±12.95)scores, (-15.37±15.32)scores, (-14.32±15.22)scores, (-20.14±16.80)scores, (-13.75±17.36)scores, (-18.72±18.57)scores, respectively. There were significant differences in improvements of DEQS total perception in different SⅠt subgroups (F=23.68, 23.31, 18.36, 14.80; P<0.05). After treatment for 14 days and 30 days, the changes of DEQS total perception in (0.70±0.80)scores, (0.90±0.87)scores, (0.90±0.85)scores, (1.20±0.95)scores, (0.90±0.78)scores, and (0.80±0.70)scores, respectively; the changes of DEQS total score were (12.69±15.73)scores, (17.82±17.10)scores, (13.87±12.67)scores, (20.39±18.55)scores, (9.45±11.13)scores and (13.55±12.41)scores, respectively. Except for no statistically significant improvement in the DEQS total score after treatment for 14 days (F=1.62, P>0.05), other intergroup comparisons were all statistically significant (F=16.25, 18.80, 5.09; P<0.05). After treatment, there was a correlation with between DEQS total score and different clinical manifestations in ≥60 years subgroup, with a statistically significant difference (|r|=0.35, 0.49, 0.33, 0.33, 0.40, 0.33; P<0.05). There was a correlation with between DEQS total perception and BUT, SⅠt in age≥60 years subgroup, with a statistically significant difference (|r|=0.54, 0.34, 0.47, 0.33; P<0.05). There was a correlation with between DEQS total score and CFS in male subgroup, with a statistically significant difference (|r|=0.31, 0.31; P<0.05). There was a correlation with between DEQS total perception between DEQS total perception and BUT in male subgroup, with a statistically significant difference (|r|=0.46, 0.32; P<0.05).

After treatment, with the improvement of physical signs, patients with different dry eyes show the corresponding improvements in the subjective symptoms. There is no correlation between signs and symptoms of dry eye in different groups of ages or sex before treatment, indicating a separation of signs and symptoms. After treatment, the changes of subjective symptoms has correlation with the improvments of objective signs in age≥60 years subgroup. After short-term treatment, the changes of subjective symptoms has correlation with the improvments of CFS and BUT in male subgroup.