Recombinant Deoxyribonuclease (DNase) Eye Drops Use in Patients with Dry Eye Disease: Results of a Randomized Clinical Trial

Abstract

Purpose : To test the hypothesis that clinical strategies that reduce the abundance of
Neutrophil Extracellular Traps (NETs) from the ocular surface will reduce signs, and symptoms of dry eye disease (DED), we performed a clinical trial using DNase eye drops.

Methods : A placebo-controlled, randomized clinical trial was performed to compare the safety and preliminary efficacy of DNase eye drops 0.1% four times a day for 8 weeks in patients (n=47) with severe tear deficient DED. Available data and intent-to-treat analyses were performed to determine the change in safety outcome measures (drug tolerability and proportion of adverse events) and efficacy outcome measures (OSDI score, corneal and conjunctival staining) between baseline and week-8.

Results : Tolerability and adverse events were similar in Placebo group and DNase group. Within the DNase group (but not placebo group), corneal staining showed a statistically significant and clinically meaningful reduction at week-8 compared to baseline. The OSDI score also showed a significant median reduction of 27.3 at week-8 compared to baseline within the DNase group. The median reduction in corneal staining (week-8 minus baseline) and mucoid debris/strands was significantly greater in the DNase group as compared to the Placebo group. In the DNase group, the median reduction in OSDI (-20.75) was more than Placebo group (-8.43); however, the difference between groups was borderline significant.

Conclusions : Treatment of severe tear deficient DED patients with DNase eye drops appears safe, well tolerated and has the potential to reduce the severity of signs and symptoms.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.