PURPOSE: To investigate the efficacy of a lubricant eye drop containing gelling agent in adult Chinese dry eye patients. METHODS: This is a prospective, randomized, double-masked, double-arm, parallel, interventional single-site clinical study. Thirty Chinese dry eye patients were randomized into two arms, 15 patients each, receiving lubricant eye drops either containing hydroxypropyl-guar (HP-guar) gelling agent (Systane Ultra) or no gelling agent (Refresh Tears), 1 drop, four times a day for 6 weeks. The main outcome measure was global symptom score (based on severity and frequency of dry eye symptoms on a visual analog scale) at weeks 1, 3, and 6. Secondary outcomes were changes in sectoral corneal fluorescein staining, tear break-up time, and Schirmer's I test results from pretreatment level. RESULTS: Both groups showed significant improvement in symptoms from baseline (p < 0.001). There was no significant difference in the global symptom score at weeks 1, 3, and 6 between the two groups. There was significantly more severe corneal fluorescein staining in the HP-guar group at baseline in the left nasal (p = 0.023) and left inferior (p = 0.046) zones, but no difference in staining was observed between the two arms at weeks 1, 3, and 6. There were no differences in Schirmer's test results or tear break-up time (final and pretreatment) between the two groups (p > 0.05). CONCLUSIONS: Both lubricant eye drops, with or without HP-guar gelling agent, benefit patients in relieving dry eye symptoms. There was no difference in the efficacy of these drugs in terms of improving symptoms and altering objective signs of dry eye.
RCT Entities:
PURPOSE: To investigate the efficacy of a lubricant eye drop containing gelling agent in adult Chinese dry eyepatients. METHODS: This is a prospective, randomized, double-masked, double-arm, parallel, interventional single-site clinical study. Thirty Chinese dry eyepatients were randomized into two arms, 15 patients each, receiving lubricant eye drops either containing hydroxypropyl-guar (HP-guar) gelling agent (Systane Ultra) or no gelling agent (Refresh Tears), 1 drop, four times a day for 6 weeks. The main outcome measure was global symptom score (based on severity and frequency of dry eye symptoms on a visual analog scale) at weeks 1, 3, and 6. Secondary outcomes were changes in sectoral corneal fluorescein staining, tear break-up time, and Schirmer's I test results from pretreatment level. RESULTS: Both groups showed significant improvement in symptoms from baseline (p < 0.001). There was no significant difference in the global symptom score at weeks 1, 3, and 6 between the two groups. There was significantly more severe corneal fluorescein staining in the HP-guar group at baseline in the left nasal (p = 0.023) and left inferior (p = 0.046) zones, but no difference in staining was observed between the two arms at weeks 1, 3, and 6. There were no differences in Schirmer's test results or tear break-up time (final and pretreatment) between the two groups (p > 0.05). CONCLUSIONS: Both lubricant eye drops, with or without HP-guar gelling agent, benefit patients in relieving dry eye symptoms. There was no difference in the efficacy of these drugs in terms of improving symptoms and altering objective signs of dry eye.