Wallerstein A, et al. - Authors compared the effectiveness and safety of a preservative-free, multi-ingredient formulation of carboxymethylcellulose 0.5%, hyaluronic acid 0.1%, and organic osmolytes (CMC-HA), to preservative-free carboxymethylcellulose 0.5% (CMC) in the management of postoperative signs and symptoms of dry eye after laser-assisted in situ keratomileusis (LASIK). Post-LASIK ocular dryness, as well as CMC alone, was relieved with CMC-HA-containing artificial tears. An incremental benefit was demonstrated by it in uncorrected vision, with a favourable safety profile. The use of CMC-HA eye drops to reduce signs and symptoms of ocular dryness post-LASIK was supported by the findings.

Methods

• Experts conducted a double-masked, randomized, parallel-group study in 14 clinical centers in Canada and Australia.
• For 90 days post-LASIK, subjects with no more than mild dry eye instilled CMC-HA or CMC
• At screening and days 2, 10, 30, 60, and 90 post-surgery, researchers evaluated Ocular Surface Disease Index (OSDI; primary efficacy measure), corneal staining, tear break-up time (TBUT), Schirmer’s test, acceptability tolerability surveys, and visual acuity.
• All enrolled were included in the safety analyses.

Results

• Findings suggested that to receive treatment, a total of 148 subjects (CMC-HA, n=75; CMC, n=73) were enrolled and assigned, and 126 subjects completed the study without any protocol violations.
• As per data, post-LASIK, dry eye signs/symptoms peaked at 10 days.
• Results demonstrated that for both, OSDI scores groups returned to normal with no differences between treatment groups at day 90 (P=0.775).
• Experts noted comparablity of corneal staining, Schirmer’s test, TBUT, and survey results.
• At all study visits, higher mean improvements in uncorrected visual acuity were observed in the CMC-HA group, reaching statistical significance at day 30 (P=0.013).
• They found well tolerability of both treatments.