Varenicline Solution Nasal Spray 0.03 Mg for the Treatment of Dry Eye Disease Following Photorefractive Keratectomy.

PURPOSE

To evaluate the use of varenicline solution nasal spray 0.03 mg (VNS) as a treatment option for the signs and symptoms of dry eye disease following photorefractive keratectomy (PRK).

PATIENTS AND METHODS

Subjects electing to undergo PRK were randomized to VNS (study group) or vehicle (control group) twice daily and started treatment with VNS 28 days prior to surgery with continued use of the treatment for 84 days after PRK. After starting treatment, subjects were seen on the day of the procedure and postoperatively at days 2, 3, 4, 7, 28 and 84. The primary outcome measure was the mean change in NEI-VFQ-25, a dry eye item questionnaire, from baseline to day 84. The second primary outcome measure was the rate of corneal epithelial healing following PRK. Secondary outcome measures included eye dryness score (EDS), tear break up time and visual outcomes. The use of rescue therapy was also evaluated.

RESULTS

Twenty-one subjects were enrolled in the study group, and twenty subjects were enrolled in the control group. Results from the NEI-VFQ-25 questionnaire revealed positive results in both groups and the between-group difference was not statistically significant (P > 0.05). There was a trend towards faster re-epithelialization in patients treated with VNS vs placebo, where 100% epithelial closure was observed by Day 3 in the VNS group versus Day 4 in the control group; however, the between-group difference was not statistically significant (P > 0.05). Three subjects had rescue therapy in the control group while a single subject was rescued in the study group. A higher rate of eyes achieved vision of 20/16 or better in the study group (82.5%) versus the control group (72.5%) at 3 months.

CONCLUSION

VNS is a favorable dry eye treatment option for patients following PRK, particularly in patients hoping to avoid additional topical medications or punctal occlusion. The higher percentage of eyes with UCDVA of 20/16 or better in the treatment group may suggest optimization of epithelial recovery after PRK.