Results from a new study published in JAMA Ophthalmology suggests that the use of perfluorohexyloctane (PCH) eye drops for dry eye disease (DED) associated with meibomian gland dysfunction (MGD) may offer well-tolerated and effective relief.
Give me some background on PCH.
Perfluorohexyloctane (PCH) eye drops consist of a preservative-free, sterile ophthalmic solution made with a water-free semifluorinated alkane. The PCH works with the lipophilic part of the tear film to form a layer at the tear film-air interface—potentially reducing water evaporation and improving DED symptoms.
Previous research has shown that PCH drops significantly improve and lipid layer quality and support tear film stability.
Talk about the study.
Conducted from February 2021 to September 2022, the randomized, multicenter, double-masked, saline-controlled, phase 3 clinical trial (NCT05515471) enrolled 312 participants from 15 hospitals in China.
Patients randomly received either PCH eye drops or 0.6% sodium chloride (NaCl) saline solution, four times a day in a 1:1 ratio.
Primary endpoints included change from baseline in total corneal fluorescein staining (tCFS) and eye dryness scores on Day 57.
What determined patient eligibility?
All patients were required to be +18 years of age, exhibit DED symptoms for 6+ months during screening as well as an ocular surface disease index (OSDI) score of 25+ and a tear film break-up time (TBUT) of 5 seconds or less.
Eligibility also included a Schirmer I test without anesthesia result of 5 mm or more at 5 minutes, a tCFS score of 4-11, and an MGD score of 3 or more.
How were they randomized?
Exactly 50% (156) of patients (mean age of 45.4 years; 75.6% female) received PCH eye drops, while the other 156 patients (mean age of 43.7 years; 81.4% female) received NaCl.
Findings?
Both primary endpoints were met, with a better change in tCFS score for the PCH group—when compared to saline (mean of -3.8 vs -2.7)—and eye dryness scores (mean of -38.6 vs -28.3).
Days 15 and 29 also showed greater improvements for both tCFS score changes and eye dryness score, respectively, and were sustained through Day 57.
Additionally, PCH-treated patients reported relief from pain, DED symptom awareness, and dryness frequency.
Any adverse effects?
Treatment-emergent adverse events (TEAEs) were reported in 34 (21.8%) participants in the PCH group and 40 (25.6%) participants in the NaCl group. Ocular TEAEs were reported in 22 (14.1%) of participants in the PCH group and 24 (15.4%) of participants in the NaCl group.
Ocular treatment-related adverse events (TRAEs) were reported in 13 (8.3%) participants in the PCH group and 7 (4.5%) participants in the NaCl group, with the most common being blurred vision, paresthesia, and eye pain.
Significance?
According to the study authors, these results suggest that the use of PCH eye drops can significantly and rapidly reduce DED signs and symptoms associated with MGD in an effective and tolerable manner.