Pilot Clinical Trial Shows DNase Eye Drops May Improve Dry Eye Symptoms
Only two drugs are currently approved to treat dry eye disease (DED). Even though it is well known that inflammation plays an important role in DED, the causes of inflammation remain largely unknown and prevent development of new treatments.
Researchers have found that neutrophils are present on the ocular surface of patients with severe tear-deficient DED subtypes that have a web-like nuclear chromatin complex (neutrophil extracellular traps [NETs]). NETs accumulate on the ocular surface in patients with DED because of hyperosmolarity or tear deficiency, suggesting that extracellular DNA (eDNA) production and clearance mechanisms are dysregulated in tear-deficient DED subtypes.
Deoxyribonuclease I (DNase) degrades and clears DNA that leaks into the extracellular space due to cell death. Because DNA forms the backbone of NETs, researchers hypothesized DNase treatment will degrade NETs. A new study in Translational Vision Science & Technology sought to determine whether DNase drops could reduce symptoms of DED.
The placebo-controlled, randomized clinical trial compared the safety and efficacy of DNase eye drops 0.1% four times per day for 8 weeks in patients with severe tear-deficient DED. Patients (N = 47) were randomly assigned to Group 1 (placebo) or Group 2 (DNase); 6 patients dropped out of the study (2 from placebo group, 4 from DNase group). Change in safety outcome measures and efficacy outcome measures were analyzed between baseline and week 8.
Tolerability and adverse events were similar between groups. In the DNase group, there was a statistically significant reduction on corneal staining at week 8 compared with baseline. OSDI scores showed a mean reduction of 27.3 at week 8 compared with baseline, and better median reduction than the placebo group (−20.75 vs −8.43, respectively).
Researchers concluded use of DNase eye drops appears safe and may reduce the severity of DED symptoms.
Mun C, Gulati S, Tibrewal S, et al. A phase I/II placebo-controlled randomized pilot clinical trial of recombinant deoxyribonuclease (DNase) eye drops use in patients with dry eye disease. Transl Vis Sci Technol. 2019;8(3):10. doi: 10.1167/tvst.8.3.10.