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Perfluorohexyloctane eye drops demonstrated significantly superior improvements in tCFS and eye dryness scores at day 57 compared with saline.
New research indicates perfluorohexyloctane eye drops (SHR8058) significantly improved the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD) with rapid efficacy in Chinese patients.
According to the data, the change from baseline at day 57 in total corneal fluorescein staining (tCFS) and eye dryness scores was superior in the perfluorohexyloctane group when compared to the control group (0.6% sodium chloride solution).
“This trial supports the use of these drops if these findings can be confirmed independently and over longer time periods,” wrote the investigative team from the Beijing Institute of Ophthalmology.
Clinical investigators have long sought new treatment options for DED, as medical and surgical management is limited. Led by Ying Jie, MD, the present clinical trial looked to evaluate the efficacy and safety of SHR8058 eye drops in patients with DED associated with MGD. The drop contains water-free semi fluorinated alkane perfluorohexyloctane, which helps form a layer at the tear film-air interface and could improve DED signs and symptoms.
The randomized, multicenter, double-masked, saline-controlled, phase 3 clinical trial was conducted from February 2021 to September 2022, with patients recruited from 15 hospitals in China. Criteria for inclusion consisted of age above 18 years, complaint of DED symptoms for ≥6 months at screening, ocular surface disease index (OSDI) score of ≥25, and tear film breakup time of 5 seconds or less.
Patients were additionally required to have a Schirmer I test without anesthesia results of ≥5 mm at 5 minutes, tCFS score of 4 – 11, and an MGD score of ≥3. Those eligible for participation were randomly assigned 1:1 to either the perfluorohexyloctane eye drops or 0.6% sodium chloride [NaCl]) 4 times per day. The primary study endpoints were the changes from baseline in tCFS and eye dryness scores at day 57.
Among 386 screened patients, 312 were included in the analysis. Of this population, 156 (mean age, 45.4 years; 118 female [75.6%]) were assigned to receive perfluorohexyloctane and 156 (mean age, 43.7 years; 127 female [81.4%] were assigned to the 0.6% NaCl group.
Upon analysis, investigators reported both primary endpoints demonstrated significant improvements in tCFS and eye dryness scores at day 57 with perfluorohexyloctane. Data showed the change from baseline in tCFS score in the perfluorohexyloctane group was superior to the saline group (mean, –3.8 vs. –2.7), as were eye dryness scores (mean, –38.6 vs. –28.3). Investigators noted estimated lsmean differences of −1.14 (95% CI, −1.70 to −0.57; P < .001) and −12.74 (95% CI, −17.20 to −8.28; P < .001), respectively.
The improvements in tCFS and eye dryness scores at days 15 and 29 were also greater in the perfluorohexyloctane group compared with the control group and were maintained through day 57, according to Jie and colleagues. Perfluorohexyloctane eye drops additionally alleviated symptoms including pain, awareness of DED symptoms, and frequency of dryness when compared with the saline group.
In the perfluorohexyloctane group, data showed treatment-emergent adverse events (TEAEs) and ocular TEAEs occurred in 34 participants (21.8%) and 22 participants (14.1%), respectively. In the control group, 40 participants (25.6%) and 24 participants (15.4%) were reported to have experienced TEAEs and ocular TEAEs, respectively. However, no adverse events led to death or treatment termination.
Jie and colleagues noted inconsistencies in DED signs and symptoms often compromise the assessment of treatment response in clinical trials and have led to failures in achieving study endpoints. However, based on the reported findings, the team suggests perfluorohexyloctane eye drops can potentially be a first-line treatment to overcome the present limitations in treating DED.
“Therefore, the findings of this study are particularly remarkable, which demonstrate improvement in both signs and symptoms of DED in a single, randomized, well-controlled clinical trial,” investigators wrote.