Perfluorohexyloctane Eyedrops for Meibomian Gland Disease
By Jean Shaw
Selected and reviewed by Neil M. Bressler, MD, and Deputy Editors
Journal Highlights
JAMA Ophthalmology, April 2023
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Perfluorohexyloctane, a preservative-free lipophilic compound, is marketed in Europe as an eyedrop for dry eye disease (DED). Tian et al. evaluated the compound’s efficacy and safety in Chinese patients who had DED associated with meibomian gland disease (MGD). They found that the perfluorhexyloctane eyedrops quickly relieved the signs and symptoms of MGD-associated DED and were safe and well-tolerated.
For this double-masked phase 3 clinical trial, the researchers recruited patients from 15 hospital ophthalmology departments in China. All participants (N = 312) were 18 years or older. They also had the following: symptoms of DED for six months or longer at screening, an ocular surface disease index (OSDI) score of ≥25, tear film breakup time (TBUT) of ≤5 seconds, Schirmer 1 test of ≥5 mm at 5 minutes, total corneal fluorescein score (tCFS) of 4 to 11 on the 15-point NEI scale, and an MGD score of ≥3.
The participants were randomly assigned 1:1 to receive either perfluorohexyloctane eyedrops or .6% saline eyedrops four times a day for nearly two months. The primary endpoints were the changes from baseline to tCFS and eye dryness scores at day 57. Results were as follows:
- This score decreased by –3.8 in the treatment group, versus –2.7 in controls.
- Eye dryness score. This dropped by –38.6 in the treatment group and by –28.3 in controls.
- This decreased by –29.9 in the treatment group, versus –23.9 in controls.
- Other measures. No significant changes in MGD, TBUT, or Schirmer 1 outcomes were noted in either group. However, those in the treatment group reported improvement in symptoms such as burning, foreign body sensation, and blurred vision.
- Adverse events. Treatment-related adverse events were noted in 34 of those who received the perfluorohexyloctane drops and in 40 of those in the control group. Perfluorohexyloctane’s safety and tolerability profile may be due to the absence of additives such as phosphates and preservatives that may negatively affect the ocular surface, the researchers wrote.
The results support the use of perfluorohexyloctane eyedrops if these findings “can be confirmed independently and over longer time periods,” the authors concluded. (Also see related commentary by Gerami D. Seitzman, MD, and Thomas M. Lietman, MD, in the same issue.)
The original article can be found here.