Evaluation of a new artificial tear formulation for the management of tear film stability and visual function in patients with dry eye

Abstract

Purpose

Artificial tears are the first line of therapy for dry eye disease (DED) and are also the most frequently used treatment approach for this common condition. Despite this, there are few published studies that directly compare the effectiveness of different drop preparations, especially those formulated specifically for dry eye. In this study, we tested a new artificial tear product, Rohto^® Dry-Aid™, for its ability to relieve the signs and symptoms of DED. The study used a second drop, Systane^® Ultra, as a positive comparator.

Materials and methods

This was a prospective, single-center, open-label, parallel-group study comparing the effects of the two products when used continuously over ~30 days (Clinical Trials registration number NCT03183089). Subjects were randomly assigned to one of the two test groups and were monitored 2 and 4 weeks after enrollment. Efficacy endpoints included ocular staining, visual function, and ocular discomfort.

Results

Treatment groups had similar ocular staining and ocular comfort scores, and both showed statistically significant ocular discomfort score improvement. Subjects in the Rohto group reported significant improvements in visual tasking activities such as watching television and driving at night. There was also a tendency for diary symptom scores to worsen from morning to evening in the Systane group, but not in the Rohto group; this trend was not significant, but warrants further study.

Conclusion

The two products, Rohto Dry-Aid and Systane Ultra, elicited comparable effects on the signs and symptoms of DED. While both products are designed to provide long-lasting relief, subjects in the Rohto group experienced a superior relief from discomfort associated with visual tasking activities and daily diaries, indicating that the Rohto drops may provide a longer duration of symptomatic relief over the course of the day.

Keywords:

• artificial tears
• dry eye
• ocular surface
• visual tasking
• blurred vision

Acknowledgments

Support of this study was provided by the Mentholatum Company, Orchard Park, NY, USA. Writing assistance provided by J McLaughlin of Ora, Inc.

Disclosure

Dr Torkildsen was clinical investigator for this study, and serves as clinical consultant at Ora, Inc. where the study was conducted. She also has received travel support from Alcon. Dr Majmudar has served as a consultant to the Mentholatum Company. Dr Brujic, Dr Cooper, Dr Karpecki, and Dr Trattler have served as consultants to Alcon and to the Mentholatum Company. Ms Reis is an employee of Rohto Mentholatum Research Laboratories, a division of The Mentholatum Company. Dr Ciolino serves as a clinical consultant at Ora, Inc. and also has served as consultant to Alcon. The authors report no other conflicts of interest in this work.