MGD-associated dry eye symptoms experience improvement following treatment with a perfluorohexyloctane eye drop, according to a study published in JAMA Ophthalmology. The novel drop demonstrated a favorable safety profile and was well-tolerated by participants, the report shows.
Investigators enrolled 312 participants with MGD-associated dry eye in a randomized, multicenter, double-masked, phase 3 clinical trial and randomly assigned participants to treatment with perfluorohexyloctane eye drops (75.6% women; mean age, 45.4 years) or saline solution (81.4% women; mean age, 43.7 years).
Participants underwent Schirmer 1 testing, tear film breakup measurement, total corneal fluorescein staining (tCFS) score assessment, and subjectively reported MGD-associated dry eye symptoms using the Ocular Surface Disease Index (OSDI). The primary endpoints were tCFS and eye dryness score changes at the 57-day study conclusion.
Both primary endpoints were achieved at the study conclusion, evidenced by tCFS score changes of -3.8 vs -2.7 and eye dryness scores changes of -38.6 vs -28.3 in the treatment and control groups, respectively. Mean differences of -1.14 (95% CI, -1.70 to -0.57) for tCFS and -12.74 (95% CI, -17.20 to -8.28) for eye dryness score revealed statistically significant symptom improvement in the treatment group compared with the control arm (P <.001 for both).
The perfluorohexyloctane eye drops not only improved MGD-associated dry eye symptoms, but lessened pain (mean tCFs score: 26.7 vs -18.7; P =.003), awareness of dry eye symptoms (mean tCFS score: -38.1 vs -23.7; P <.001), and frequency of dryness (mean tCFS score: -43.3 vs -29.1; P <.001) in the treatment group compared saline solution.
Adverse events occurred in 34 participants (21.8%) in the perfluorohexyloctane group compared with 40 participants (25.6%) in the control group.
“[T]he application of perfluorohexyloctane was safe, improved clinical signs and symptoms of DED associated with MGD, and resulted in great satisfaction and willingness to continue using it beyond the specified duration of this trial,” according to the researchers. “The excellent safety and tolerability profile of perfluorohexyloctane may be due to the absence of additives such as phosphates and preservatives that may affect the ocular surface adversely or cause blurring.”
Study limitations include a short study duration, the exclusion of patients who wore contacts or had secondary dry eye, and ethnic homogeneity among the MGD-associated dry eye cohorts which may have limited the globalization of these findings.
Tian L, Gao Z, Zhu L, et al. Perfluorohexyloctane eye drops for dry eye disease associated with meibomian gland dysfunction in chinese patients: a randomized clinical trial. JAMA Ophthalmol. Published online March 16, 2023. doi:10.1001/jamaophthalmol.2023.0270