Statistically significant differences in both symptom and sign assessments, were seen at various time points throughout the study. Of particular note at day 56, the treated group had 35.1% reduction of ocular discomfort compared with vehicle control, and 59.1% reduction of total corneal fluorescein staining compared with vehicle control. Other improvements seen in the RGN-259–treated patients included tear film breakup time and increased tear volume production.
Conclusions: In this small trial, RGN-259 eye drops were safe and well tolerated and met key efficacy objectives with statistically significant symptom and sign improvements, compared with vehicle control, at various time intervals, including 28-days posttreatment.