A clinical trial conducted in China demonstrated that perfluorohexyloctane eye drops significantly improved the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD). The findings were published in Journal of American Medical Association.
A randomized, multicenter, double-masked, saline-controlled, phase 3 clinical trial was conducted from February 4, 2021, to September 7, 2022. A total of 312 participants were recruited from 15 hospitals in China, and those with DED associated with MGD were enrolled between February 4 and July 1, 2021.
The diagnosis was based on patient complaints of DED symptoms, an ocular surface disease index of 25 or higher, tear film break-up time of 5 seconds or less, Schirmer I test without anesthesia results of 5 mm or more at 5 minutes, total corneal fluorescein staining (tCFS) score of 4 to 11, and an MGD score of 3 or higher. Eligible participants were randomly assigned 1:1 to receive perfluorohexyloctane eye drops or 0.6% sodium chloride (NaCl) 4 times per day.
Perfluorohexyloctane eye drops significantly improved tCFS score and eye dryness score compared to the NaCl group. Improvements in both endpoints appeared to be noted on day 29 and day 15, respectively, and were maintained through day 57.
Perfluorohexyloctane eye drops also alleviated other symptoms such as pain, awareness of DED symptoms, and frequency of dryness compared to the control group. Treatment-emergent adverse events occurred in 34 participants (21.8%) in the perfluorohexyloctane group and 40 participants (25.6%) in the NaCl group, demonstrating the safety and tolerability of the eye drops.
Perfluorohexyloctane eye drops are an effective and safe treatment option for DED associated with MGD, with a rapid onset of action and satisfactory tolerability and safety through 57 days. Future studies are necessary to confirm these results independently and over longer periods to establish the long-term safety and efficacy of the eye drops.
Source:
Tian, L., Gao, Z., Zhu, L., Shi, X., Zhao, S., Gu, H., Xu, G., Wang, L., Dai, H., Zhang, H., Jin, X., Ma, K., Xu, Y., Ma, L., Pei, C., Ke, B., Krösser, S., Zhang, Y., & Jie, Y. (2023). Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients. In JAMA Ophthalmology. American Medical Association (AMA). https://doi.org/10.1001/jamaophthalmol.2023.0270