DNSO Eye Drops Safety Profile
DNase (deoxyribonuclease) eye drops at 0.1% concentration appear safe and well-tolerated based on the single available clinical trial, showing no significant adverse events compared to placebo in patients with severe dry eye disease. 1
Evidence Quality and Limitations
The safety data for DNase eye drops comes from a single Phase I/II pilot trial published in 2019, which represents limited but promising evidence. 1 This study specifically evaluated DNase 0.1% eye drops used four times daily for 8 weeks in patients with severe tear-deficient dry eye disease. 1
Safety Findings
- Tolerability was comparable between DNase and placebo groups, with no significant difference in adverse event rates. 1
- The study demonstrated that DNase eye drops were well-tolerated throughout the 8-week treatment period. 1
- No serious ocular or systemic adverse effects were reported in the DNase treatment group. 1
Efficacy Data Supporting Safety Profile
Beyond safety, the trial showed therapeutic benefit, which supports continued investigation:
- Corneal staining showed statistically significant and clinically meaningful reduction at week 8 within the DNase group. 1
- The Ocular Surface Disease Index (OSDI) score demonstrated a significant median reduction of 27.3 points at week 8 compared to baseline. 1
- The median reduction in corneal staining and mucoid debris was significantly greater in the DNase group compared to placebo. 1
Mechanism and Rationale
DNase eye drops work by degrading neutrophil extracellular traps (NETs) from the ocular surface, which may contribute to their therapeutic effect in dry eye disease. 1
Critical Caveats
- This is investigational therapy - DNase eye drops are not FDA-approved for ophthalmic use and are not part of standard dry eye treatment guidelines. 2
- Limited long-term safety data - only 8 weeks of treatment data are available from a single pilot study. 1
- Small sample size - as a pilot trial, the number of patients studied was limited, restricting the ability to detect rare adverse events. 1
- Not commercially available - DNase eye drops are not currently available as a standard treatment option for dry eye disease. 1
Standard Treatment Alternatives
For patients with dry eye disease, established first-line treatments with extensive safety profiles include: