PURPOSE: To compare the efficacies of sodium hyaluronate, hydroxypropyl methylcellulose (HPMC), and a new oil-in-water emulsion (Emustil unidose; SIFI) in the management of lipid-deficient dry eye. METHODS:Seventy-five subjects with dry eye were randomly divided into 3 groups. Each was allocated sodium hyaluronate, HPMC, or emulsion eyedrops to be used four times daily for 90 days. Parameters were measured at baseline, 30 days, and 90 days. A compliance visit was performed at days 7 and 60. RESULTS: Significant reduction (P < 0.05) in evaporation and improvement in symptoms in all groups were found. No statistically significant increase in tear turnover rate (TTR) was found with any solution. A significant difference in tear stability and noninvasive tear break-up time (NITBUT) was found in the emulsion and sodium hyaluronate groups but not in the HPMC group (P > 0.05). There was a significant decrease in osmolarity and corneal staining in the emulsion group (P < 0.001) but not in the sodium hyaluronate or HPMC group (P > 0.05). CONCLUSIONS: A significant reduction in evaporation and improvement in symptoms in all therapy groups were found from baseline to 90 days. However, no significant effect was seen on TTR for any group. The emulsion drops were shown to perform best, improving tear stability, and decreasing osmolarity and corneal staining. These results are consistent with improvements in the lipid layer of the tear film as a result of prolonged use of emulsion drops.
RCT Entities:
PURPOSE: To compare the efficacies of sodium hyaluronate, hydroxypropyl methylcellulose (HPMC), and a new oil-in-water emulsion (Emustil unidose; SIFI) in the management of lipid-deficient dry eye. METHODS: Seventy-five subjects with dry eye were randomly divided into 3 groups. Each was allocated sodium hyaluronate, HPMC, or emulsion eyedrops to be used four times daily for 90 days. Parameters were measured at baseline, 30 days, and 90 days. A compliance visit was performed at days 7 and 60. RESULTS: Significant reduction (P < 0.05) in evaporation and improvement in symptoms in all groups were found. No statistically significant increase in tear turnover rate (TTR) was found with any solution. A significant difference in tear stability and noninvasive tear break-up time (NITBUT) was found in the emulsion and sodium hyaluronate groups but not in the HPMC group (P > 0.05). There was a significant decrease in osmolarity and corneal staining in the emulsion group (P < 0.001) but not in the sodium hyaluronate or HPMC group (P > 0.05). CONCLUSIONS: A significant reduction in evaporation and improvement in symptoms in all therapy groups were found from baseline to 90 days. However, no significant effect was seen on TTR for any group. The emulsion drops were shown to perform best, improving tear stability, and decreasing osmolarity and corneal staining. These results are consistent with improvements in the lipid layer of the tear film as a result of prolonged use of emulsion drops.
Authors: Marjan Farid; Anshu Agrawal; Daniel Fremgen; Jeremiah Tao; He Chuyi; Anthony B Nesburn; Lbachir BenMohamed Journal: Ocul Immunol Inflamm Date: 2014-12-23 Impact factor: 3.070