Evaluation of Systane Complete for the Treatment of Contact Lens Discomfort

Abstract

Purpose: To understand if a new artificial tear, which is indicated for the treatment of both evaporative and aqueous deficient dry eye, is able to safely alleviate contact lens discomfort (CLD) in symptomatic soft contact lens (CL) wearers.

Methods: This registered, investigator-masked, two-week, randomized clinical trial recruited adult subjects with symptomatic Contact Lens Dry Eye Questionanire-8 (CLDEQ-8 scores ≥ 12) scores. Subjects were randomized to use artificial tears (Systane Complete) before and after CL use or no treatment. Clinical signs (visual acuity, tear breakup time, corneal staining, Schirmer's test I, and meibum quality and expression) and symptoms (CLDEQ-8, Standardized Patient Evaluation of Eye Dryness (SPEED), self-reported) were evaluated at baseline and two weeks.

Results: This study recruited 22 subjects who were randomized to artificial tears and 24 subjects who were randomized to no treatment. Subjects in the artificial tears group had significantly better CLDEQ-8 scores (12.86 ± 6.40 vs. 17.92 ± 5.30; p = 0.006) but not SPEED scores (7.55 ± 4.31 vs. 9.29 ± 4.14; p = 0.17) at two weeks compared to the no treatment group. No significant between group differences were noted for any clinical signs at two weeks (all p > 0.29). No subject in either group reported any adverse events during the study.

Conclusions: Systane Complete was found to safely and significantly improve CL comfort in symptomatic CL wearers. Additional work is needed to better understand the mechanism(s) leading to improved comfort since tested clinical signs were unchanged.

Keywords: Artificial tears; Clinical trial; Contact lens discomfort; Dry eye; Systane complete.