First In Human Clinical Investigation Of A Soft, Insoluble, Daily-Use Ocular Insert For Its Potential Use For Treatment Of Dry Eye

To evaluate the safety and comfort of a soft, insoluble, daily-use ocular insert for its potential use for the treatment of dry eye.

Tertiary referral ophthalmology center (Centro de Oftalmología Barraquer, Barcelona, Spain) between October 2023 and July 2024.

This first in human, open-label, single-arm prospective interventional study, included 20 healthy subjects. The investigational ocular insert is a Class IIa medical device made of biocellulose containing solution of balanced salt solution and ultrapure water. Two devices size were evaluated: large (16 × 4 mm) and medium (8 × 3 mm). After screening, volunteers were instructed to wear the device for 15 minutes, 1 hour, 3 hours, and 6 hours sessions. After removal, examinations were conducted, including NIBUT, slit lamp evaluation to assess hyperemia, corneal and conjunctival punctate staining using lissamine green and fluorescein, and symptom questionnaire completion.

Twenty subjects completed the study. Seventeen used only the large insert, while 3 switched to the medium insert based on tolerability criteria. Overall, 78 wearing sessions were performed with the large insert and 6 with the medium insert. Dislodgements occurred with the large insert in 10 sessions at different wearing times. No dislodgements occurred with the medium insert. Moderate discomfort was reported in 6% (5/78) of sessions with the large insert, with symptoms decreasing over time, but was not observed with the medium insert. Adverse effects were minimal, with only one instance of slight hyperemia and one case of mild nasal conjunctival staining. No impact on tear film stability was observed.

This study demonstrates that the device is safe and well tolerated. Comfort and retention improved with user experience. These results support further investigation in patients with dry eye disease as a slow-releasing tears reservoir.