RESUMO
PURPOSE: To evaluate the ability of Systane(®) Balance (SYSB) administered four times per day for 4 weeks to increase noninvasive tear film break-up time (NITFBUT) over baseline compared with a saline (SAL) control in patients with lipid-deficient dry eye (DE). PATIENTS AND METHODS: Patients aged ≥18 years with DE and evidence of meibomian gland dysfunction (ie, abnormal gland expression and missing meibomian glands) were included in this randomized, parallel-group, controlled, investigator-masked comparison study. Patients were randomized to SYSB or SAL four times daily for 4 weeks. The primary efficacy variable was mean change in NITFBUT from baseline at week 4. Ocular surface staining, goblet cell density, and meibomian gland expression were also assessed. Safety assessments included adverse events (AEs), best-corrected visual acuity, and ocular signs. RESULTS: A total of 49 patients received study treatments (SYSB, n=25; SAL, n=24). Most patients were women (67.4%) and Caucasian (63.3%); mean ± standard deviation (SD) age was 44±19 years. DE characteristics at baseline were similar between groups. After 4 weeks of treatment, the mean ± SD NITFBUT increase from baseline was significantly greater with SYSB (2.83±0.74 seconds) compared with SAL (0.66±0.55 seconds; P<0.001, t-test). Improvements in conjunctival and corneal staining, percentage of patients with increased goblet cell density, and meibomian gland expression were also observed with 4 weeks of SYSB over SAL. No AEs were reported for either treatment group; best-corrected visual acuity and ocular signs remained stable or improved compared with baseline. CONCLUSION: SYSB restored tear film stability, improved ocular surface healing, and improved meibomian gland functionality after 4 weeks of use in patients with lipid-deficient DE. No AEs were reported with either SYSB or SAL.
RESUMO
El ojo seco es una compleja enfermedad multifactorial de la película lagrimal y de la superficie ocular caracterizada por síntomas de desconforto, alteraciones de la visión e inestabilidad del film lagrimal que puede provocar daño potencial sobre la superficie ocular. La inestabilidad del film producirá aumentos en la osmolaridad de la película lagrimal, lo que desencadena a su vez lesiones osmóticas epiteliales e inflamación. Al producirse estos cambios sobre la superficie ocular, los mecanismos neurofisiológicos de homeostasis se verán alterados lo que complicará aún más el proceso, con la aparición de circuitos viciosos fisiopatológicos.
Dry eye is a complex multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Inestability of the tear film may also cause an increased osmolarity of the tear film, thus triggering epithelial osmotic lesions and inflammation. The occurrence of such changes on the eye surface results in disturbances of homeostatic neurophysiologic mechanisms which further worsen the process and vicious pathophysiological cycles occur.
Assuntos
Humanos , Síndromes do Olho Seco/metabolismo , Lágrimas/química , Concentração OsmolarRESUMO
Dry eye is a complex multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Inestability of the tear film may also cause an increased osmolarity of the tear film, thus triggering epithelial osmotic lesions and inflammation. The occurrence of such changes on the eye surface results in disturbances of homeostatic neurophysiologic mechanisms which further worsen the process and vicious pathophysiological cycles occur.
