Perfluorohexyloctane Eyedrops safe for contact lens wearers and may reduce contact lens dropout: Study
Dry eye disease (DED) is one of the most common disorders. The incidence of DED has been increasing over the past several years. There are two major subgroups of DED, aqueous-deficient DED, which results from reduced lacrimal gland secretions, and evaporative DED, which results from excessive evaporation of the tear film. The majority of DED cases have an underlying evaporative component, and the primary cause of evaporative DED is meibomian gland dysfunction (MGD). MGD causes alterations in the tear film lipid layer which contributes to tear film instability and increased evaporation of the aqueous layer. Tear film instability associated with MGD leads to tear hyperosmolarity, resulting in apoptosis and inflammation of the ocular surface.
Patients suffering from DED complain of symptoms including irritation, dryness, burning or stinging and visual disturbances. These symptoms may adversely affect the patient’s quality of life and work productivity. Signs of DED include tear film instability (eg, reduced tear film breakup time (TBUT)), and conjunctival redness. Many therapies are being used to help treat MGD, including physical therapies (eg, gland expression, thermal pulsation, intense pulsed light), oral medications (eg, doxycycline, azithromycin) with the intention of reducing inflammation or lowering meibum viscosity, and over the counter lipid based tears to replenish the tear film lipid layer temporarily. Immunomodulatory or anti-inflammatory drugs such as cyclosporine, lifitegrast, and loteprednol etabonate are also being used for the treatment of DED but are not approved for the treatment of MGD.
According to the TFOS DEWS II Iatrogenic Report, contact lenses can significantly impact dry eye syndrome (DES). The mechanical interaction between the lens and the ocular surface can disrupt the tear film, leading to increased evaporation and instability. Contact lens wear can also reduce corneal sensitivity and alter tear production. Long-term use of contact lenses is associated with meibomian gland dysfunction, further contributing to DES symptoms. Specifically, contact lens-induced dry eye (CLIDE) and contact lens-associated dry eye (CLADE) are recognized conditions where lens wear exacerbates dry eye symptoms.
Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO®) (Bausch + Lomb) is a novel, non-aqueous, single entity, preservative-free ophthalmic drop recently approved by the FDA for treatment of the signs and symptoms of dry eye disease. This sterile, clear, colorless liquid containing 100% perfluorohexyloctane is approved for topical ophthalmic use four times daily. Although its exact mechanism in DED is unknown, PFHO is effective in reducing tear film evaporation by forming a monolayer at the tear film’s air–liquid interface. Its low surface tension facilitates rapid spreading across the tear film, causing minimal visual disturbance due to its refractive index similar to water.
Both Phase 3 trials (GOBI and MOJAVE) demonstrated significant improvements in both signs and symptoms of DED compared to hypotonic saline, with good tolerability. In addition, 100% of the patients enrolled in both trials also had clinically diagnosed meibomian gland dysfunction. While the safety and efficacy of PFHO has been demonstrated in non-contact lens wearers, its safety and potential benefits in habitual contact lens wearers have not been explored. This report presented the results of a trial designed to evaluate the safety of PFHO and its effect on contact lens comfort, specifically in established contact lens wearers.
While the safety and efficacy of PFHO has been demonstrated in non-contact lens wearers, its safety and potential benefits in habitual contact lens wearers have not been explored. This report presents the results of a trial designed to evaluate the safety of PFHO and its effect on contact lens comfort, specifically in established contact lens wearers.
The study included 47 patients who were adjusted contact lens wearers with a best corrected visual acuity of 20/25 or better at distance. All the patients were healthy contact lens wearers with no dry eye symptoms. A significant improvement in comfort scoring was observed without any significant changes in osmolarity, meibography scores, and total fluorescein staining.
PFHO, administered 4 times daily for 4 weeks in patients wearing soft contact lenses, has shown to be safe and well tolerated when used as directed by the manufacturer. These findings are noteworthy, given that demonstration of safe use of PFHO in soft contact lens wearers has not been evaluated from other studies. PFHO also demonstrated a significant improvement in contact lens comfort. These results are even more interesting given that these patients were not dry eye patients. There were no serious ocular or nonocular AEs reported in patients treated with PFHO in this study. Limitations of the current study include the relatively short treatment period of 4 weeks and not exclusively evaluating contact lens wearers with dry eye disease. Further research is needed to explore the mechanisms driving changes in comfort and their relation to tear film stability. A future study where patients do not remove their contact lenses when instilling PFHO could also be considered.
The conclusion in this study is that PFHO is a safe product to utilize for soft contact lens wearers when used as directed by the manufacturer. The study demonstrated no statistically significant adverse changes to the ocular surface while showing statistically significant improvement in comfort.
Source: Geffen and Pennell; Clinical Ophthalmology 2024:18
https://doi.org/10.2147/OPTH.S487897
