COMPARISON OF EFFICACY AND SAFETY OF TWO ARTIFICIAL TEARS IN PATIENTS WITH MILD TO MODERATE DRY EYE SYMPTOMS: A RANDOMIZED, PARALLEL STUDY
Journal Title: European Journal of Biomedical and Pharmaceutical Sciences - Year 2019, Vol 6, Issue 10
Abstract
Purpose: Artificial tears are commonly used for symptomatic treatment of dry eye disease (DED). We compared the efficacy and safety of two preservative-free lubricant eye drops; Osmodrops (carboxymethylcellulose 0.5%, glycerin 0.9%; Cipla Ltd.) and OptiveTM (carboxymethyl cellulose 0.5%; Allergan Inc.) in patients with mild to moderate DED. Methods: In this prospective randomized study, patients with mild to moderate DED (Dry Eye severity level 2 as per Dry Eye Workshop [DEWS] II grading system) were randomized (1:1) to receive Osmodrops or Optive 4 times daily for the duration of 8 weeks. Efficacy outcomes included Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), and corneal fluorescein staining. Safety outcomes included the number and frequency of adverse events (AE). Results: Out of 178 patients enrolled, 93 (52.25%) and 85 (47.75%) were randomized to receive Osmodrops and Optive eye drops, respectively. After 8 weeks, both groups demonstrated benefit in alleviating the ocular symptoms. The mean OSDI score significantly declined from baseline to weeks 4 and 8 in Osmodrops (69.00±11.27 to 44.89±8.17 and 24.29±8.06, p<0.001) and Optive (69.58±10.63 to 47.22±8.30 and 25.23±9.75, p<0.001) groups. There was no significant difference in OSDI scores between the groups at either of the study visits. Patients in both groups exhibited significant improvement in TBUT and corneal fluorescein staining scores at weeks 4 and 8 (p<0.001). No AEs were reported. Conclusions: Both eye drops were found to be effective in decreasing the OSDI score and improving the tear film stability in patients with mild to moderate dry eye symptoms.
Authors and Affiliations
Dr. Prasanna Aradhye
Keywords
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