The Effect of Varenicline Nasal Spray on the Signs and Symptoms of Dry Eye Disease and Tear Film Stability: A Randomized Controlled Trial.

PURPOSE: To evaluate the effect of varenicline nasal spray (VNS) 0.03 mg on the signs and symptoms of dry eye disease (DED) and tear film stability. PATIENTS AND METHODS: In this prospective, placebo-controlled study, 50 DED subjects were randomized to receive either VNS 0.03 mg nasal spray or its vehicle twice daily for 28 days. Study parameters included dry eye questionnaire score (DEQS), eye dryness score (EDS), corneal (CFS) and conjunctival fluorescein staining, non-invasive tear break-up time (TBUT), surface asymmetry index (SAI), and surface regularity index (SRI). RESULTS: Post treatment, the improvement in mean symptom scores, including DEQS (23% vs 12%, p=0.022) and EDS (44% vs 27%, p = 0.012), was significantly higher in the VNS group compared to the vehicle group. The mean CFS and conjunctival staining scores also showed significantly higher improvement (~50% vs ~20%, p<0.001) in the VNS group compared to the vehicle. The mean change in non-invasive TBUT was higher in the VNS group (70% vs 30%, p = 0.680). The mean improvement in SAI and SRI were comparable between the two groups. There were no serious adverse events in either group. CONCLUSION: There was a statistically significant improvement in the symptoms and signs of DED in the VNS group. These results indicate that improving natural tear production using VNS nasal spray can help foster tear film stability and ocular homeostasis over time. CLINICALTRIALSGOV IDENTIFIER: NCT05514041.