Jong Hwa Jun1, Seung Pil Bang1, Han Sang Park2, Donghee Yoon2, Ja Young Ahn3,4, Seong Jae Kim3,4, Hong Kyun Kim5,6. 1. Department of Ophthalmology, Keimyung University School of Medicine, Daegu, Republic of Korea. 2. Department of Ophthalmology, Kyungpook National University Hospital, Daegu, Republic of Korea. 3. Department of Ophthalmology, Gyeongsang National University School of Medicine, Jinju, Republic of Korea. 4. Institute of Health Sciences, Gyeongsang National University School of Medicine, Jinju, Republic of Korea. 5. Department of Ophthalmology, Kyungpook National University Hospital, Daegu, Republic of Korea. okeye@knu.ac.kr. 6. Department of Ophthalmology, School of Medicine, Kyungpook National University, #130 Dongdeok-ro, Joong-gu, Daegu, 41944, Republic of Korea. okeye@knu.ac.kr.
Abstract
PURPOSE: We report the clinical efficacy of sequential applications of 0.3% and 0.15% unpreserved hyaluronic acid (HA) for the treatment of dry eye disease (DED). STUDY DESIGN: Randomized clinical trial. METHODS: Patients over 19 years of age with DED level 2 or higher, corneal fluorescein staining (CFS) score > 1, and tear break-up time (TBUT) < 10 s were included. Seventy-six patients were randomly assigned to the 0.15% HA group, 0.3% HA group, or combination group. Each group applied two drops of 0.15% or 0.3% HA, or a single drop of both 0.3% and 0.15% HA. Patients were evaluated using the ocular surface disease index (OSDI), CFS and conjunctival fluorescein stain score, TBUT, and blurring/discomfort after application at baseline, 4 weeks, and 8 weeks. RESULTS: The combination group had the greatest improvement in CFS score from baseline to 8 weeks, compared with the 0.15% and 0.3% HA group (p < 0.001). The combined CFS-OSDI responder rates of the combination group (CFS score = 0 and OSDI ≥ 50% improvement at 8 weeks) were significantly higher than those of the 0.15% and 0.3% groups (p = 0.037). At 4 and 8 weeks, blurring after application in both the 0.3% and combination groups was significantly higher than in the 0.15% group, despite no difference between the 0.3% and combination groups. There were no differences in CFS and conjunctival staining score, TBUT, or OSDI within the three groups at baseline, 4 weeks, and 8 weeks. CONCLUSIONS: Sequential application of 0.3% and 0.15% HA improved symptoms/signs in moderate to severe DED patients.
PURPOSE: We report the clinical efficacy of sequential applications of 0.3% and 0.15% unpreserved hyaluronic acid (HA) for the treatment of dry eye disease (DED). STUDY DESIGN: Randomized clinical trial. METHODS: Patients over 19 years of age with DED level 2 or higher, corneal fluorescein staining (CFS) score > 1, and tear break-up time (TBUT) < 10 s were included. Seventy-six patients were randomly assigned to the 0.15% HA group, 0.3% HA group, or combination group. Each group applied two drops of 0.15% or 0.3% HA, or a single drop of both 0.3% and 0.15% HA. Patients were evaluated using the ocular surface disease index (OSDI), CFS and conjunctival fluorescein stain score, TBUT, and blurring/discomfort after application at baseline, 4 weeks, and 8 weeks. RESULTS: The combination group had the greatest improvement in CFS score from baseline to 8 weeks, compared with the 0.15% and 0.3% HA group (p < 0.001). The combined CFS-OSDI responder rates of the combination group (CFS score = 0 and OSDI ≥ 50% improvement at 8 weeks) were significantly higher than those of the 0.15% and 0.3% groups (p = 0.037). At 4 and 8 weeks, blurring after application in both the 0.3% and combination groups was significantly higher than in the 0.15% group, despite no difference between the 0.3% and combination groups. There were no differences in CFS and conjunctival staining score, TBUT, or OSDI within the three groups at baseline, 4 weeks, and 8 weeks. CONCLUSIONS: Sequential application of 0.3% and 0.15% HA improved symptoms/signs in moderate to severe DED patients.