| Popis: |
Hans-Walter Roth1, Taryn Conway2, David A Hollander21Institut für Wissenschaftliche Kontaktoptik Ulm, Ulm/Donau, Germany; 2Allergan, Inc, Irvine, CA, USABackground: Artificial tears are commonly used for the symptomatic treatment of dry eye. This study compared the efficacy and safety of two preservative-free formulations of artificial tears, carboxymethylcellulose 0.5%/glycerin 0.9% (CMC/glycerin) and sodium hyaluronate 0.18% (sodium hyaluronate), in patients with mild to moderate dry eye symptoms.Methods: This multicenter, investigator-masked, randomized, parallel-group, active-controlled, clinical study enrolled patients with mild to moderate dry eye symptoms. At baseline, patients received both treatments (one in each eye) and completed an Acute Preference Questionnaire. Patients were then randomized 1:1 to treatment with one drop of CMC/glycerin or sodium hyaluronate at least three times per day for 2 weeks. Efficacy outcomes included Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), corneal staining, conjunctival staining, conjunctival hyperemia, Dry Eye Symptom and Bothersomeness Survey, Patient Acceptability Questionnaire, and Patient Global Assessment of Change. Safety outcomes included the number and frequency of adverse events.Results: CMC/glycerin and sodium hyaluronate produced statistically significant improvements in OSDI (P < 0.0001), TBUT (P < 0.0001), corneal staining (P < 0.0001), conjunctival staining (P < 0.0001 at Week 1; P < 0.01 at Week 2), and conjunctival hyperemia (P < 0.0001 at Week 1; P < 0.05 at Week 2) relative to baseline. No statistically significant between-group differences in any evaluated variable, including clinical and patient-reported outcomes, were observed. Following a single-drop instillation, there was a trend in favor of sodium hyaluronate for which each drop produced less blurring (P = 0.055). At Day 14, there were trends in favor of CMC/glycerin for questions about how many hours the eyedrops controlled symptoms (P = 0.057), whether the eyedrops effectively relieved dryness (P = 0.053), and which drop provided a cushion of moisture on eyes (P = 0.052). No treatment-related adverse events were reported.Conclusion: Both CMC/glycerin and sodium hyaluronate effectively relieved dry eye symptoms. Scores were consistently similar across all measures, and both artificial tears were highly acceptable to patients.Keywords: artificial tears, dry eye, safety, efficacy, carboxymethylcellulose 0.5%/glycerin 0.9%, sodium hyaluronate 0.18% |
