Cross-linked hyaluronic acid gel occlusive device for the treatment of dry eye syndrome

Abstract

Purpose: A new cross-linked hyaluronic acid (xlHA) gel occlusive device was assessed for safety and efficacy in the treatment of dry eyes. Methods: This was an institutional review board-approved, single-site, open-label, prospective study to assess the efficacy and safety of placing the xlHA gel in the lower canaliculus. Seventy-four participants aged 25–95 years with dry eyes, who failed treatment with artificial tears, were included. Patients were assessed with corneal slit lamp examination with fluorescein staining and with Schirmer’s test, breakup time (TBUT), and tear meniscus height (TMH) at baseline, 1 month, and 3 months. Patients were followed at 6 months with a telephone questionnaire. The procedure entailed inserting ~0.2 mL of xlHA gel into each lower lid canaliculus with a syringe and lacrimal irrigator. Patients were followed for adverse events. Results: Sixty-three patients completed the study (48 females, 15 males), with an average age of 67 years. Slit lamp demonstrated improved corneal fluorescein staining. Schirmer’s tests demonstrated an average increase over baseline of 3.67 mm after 3 months. TBUT improved 87% and TMH increased by 57% at 3 months over baseline. All objective measures were statically significant. There was one case of conjunctivitis that resolved and was felt to be an incidental viral infection. Conclusion: The xlHA Occlusive Device offers a new, safe, and effective method to treat dry eyes. It appears to have efficacy for at least 3 months on clinical examination. The xlHA gel demonstrated a good tolerance and safety profile.