Efficacy and Safety of Perfluorohexyloctane in Evaporative Dry Eye Disease Associated With Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Meibomian gland dysfunction (MGD) is the primary cause of evaporative dry eye disease (DED), which negatively affects the physical and mental quality of life of patients. We performed a meta-analysis of randomized controlled trials (RCTs) comparing perfluorohexyloctane to placebo for MGD in order to identify the best course of treatment for DED in these patients. We followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guideline recommendations and prospectively registered the study in PROSPERO (CRD42023442172). The PubMed, Cochrane, and Embase databases were searched for RCTs comparing perfluorohexyloctane to placebo on patients with DED associated with MGD. The statistical analysis was carried out using the "R" software. The mean difference (MD) with 95% CIs was computed using a random-effects model, and p < 0.05 was regarded as statistically significant. The study included 1,814 patients from four RCTs, of whom 972 (53.5%) received perfluorohexyloctane. Patients treated with perfluorohexyloctane had significantly lower total corneal fluorescein staining (tCFS) score (MD -1.09; 95% CI -1.37 to -0.82; p < 0.001; I² = 0%), eye distress Visual Analogue Scale (VAS) (MD -9.69; 95% CI -12.01 to -7.36; p < 0.01; I² = 0%), Ocular Surface Disease Index (OSDI) (MD -5.79; 95% CI -8.22 to -3.36 p < 0.01; I² = 0%), and Eye Burning/Stinging Score (VAS) (MD, -7.16; 95% CI -9.55 to -4.80 p < 0.01; I² = 0%). The meta-analysis results indicate that perfluorohexyloctane was effective and safe in treating evaporative dry eye, reducing tCFS, eye discomfort, OSDI, and burning sensation, despite the included studies only assessing short-term effects and excluding certain patient groups.

Keywords: dry eye; meibomian gland dysfunction; meta-analysis; nov03; perfluorohexyloctane.

Figure 1. PRISMA flow diagram of the study screening and selection process

PRISMA, Preferred Reporting Items for Systematic reviews and Meta-Analyses

Figure 2. Eye Burning/Stinging Score forest plot

This forest plot depicts the change in Eye Burning/Stinging Score (measured by VAS) from baseline to week 8 across different treatment groups. VAS, Visual Analogue Scale

Figure 3. Central NEI forest plot

This forest plot shows the change in the Central Corneal Fluorescein Staining Score (NEI scale) from baseline to week 8 across different treatment groups.

Figure 4. Eye Distress VAS forest plot

This forest plot shows the change in Eye Dryness Score (measured by VAS) from baseline to week 8 across different treatment groups. VAS, Visual Analogue Scale

Figure 5. Ocular adverse events forest plot

This figure presents a forest plot summarizing the influence of adverse ocular events in different treatment groups.

Figure 6. OSDI forest plot

This forest plot illustrates the variation in OSDI scores from baseline to follow-up across different treatment groups, displaying effect sizes and CIs to highlight the impact of various interventions on ocular surface health. OSDI, Ocular Surface Disease Index

Figure 7. Risk of bias

Visual representations, such as summary plots and individual study plots using ROB 2, are widely used tools for assessing the risk of bias in RCTs. RCT, randomized controlled trial; ROB 2, Risk of Bias 2