Abstract
Purpose :
To investigate the efficacy of topical administration of a transient receptor potential melastatin 8 (TRPM8) agonist in patients with dry eye disease.
Methods :
In this randomized prospective double-masked study, 60 subjects (60 eyes) with mild to moderate dry eye disease were recruited and allocated to two groups: a TRPM8 agonist (1-diisopropylphosphorylnonane; group A) or vehicle (group B). Study medications were topically applied 4 times a day for 2 weeks to the upper eyelids using a single unit applicator containing the TRPM8 agonist, 2 mg/mL in water, or vehicle. Tear film break-up time (TBUT), Schirmer score, and keratoepitheliopahty (KEP) score were analyzed before and at 1 and 2 weeks thereafter. In addition, dry eye symptoms assessed by the visual analogue scale (VAS), ocular surface disease index (OSDI), and grade of computer vision syndrome (CVS) were evaluated before and after application.
Results :
The changes in TBUT and KEP were not significant in both groups. The Schirmer score increased in group A at 1 and 2 weeks when compared to baseline and when compared to group B (p<0.05). The changes in ocular symptoms scores, assessed by three questionnaires, showed that the VAS and total OSDI scores were improved at 2 week and the CVS score at 1 and 2 weeks in group A compared to group B (p<0.05). No significant adverse effect such as ocular pain, irritation, or discomfort was reported from both groups during the study period.
Conclusions :
Daily topical application of the TRPM8 agonist on the eyelid skin was safe and effective in improving tear secretion and ocular symptoms in patients with dry eye. The agent is a promising candidate for further exploration of TRPM8 function on the ocular surface and for use in the relief of dry eye discomfort.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.