Clinical evaluation of new canalicular insert for treatment of dry eye disease

Abstract

Purpose : To evaluate safety, tolerability, performance, and efficacy of a new and novel canalicular insert, iLIEF™ Canalicular Insert, in a single center, open label clinical trial in dry eye patients. iLIEF is an erodible insert comprised of ingredients found in artificial tears used to treat both aqueous deficient and evaporative dry eye patients.

Methods : The trial randomized 50 dry eye patients (non-Sjogren syndrome) who previously used an artificial tear/ocular lubricant. iLIEF was inserted bilaterally into the lower canaliculus of all patients. The primary performance endpoint was retention of iLIEF at Week 6 and Week 12 as evidenced by a negative Jones test I, and removability of iLIEF at Week 6 (N=25 patients) and Week 52 (N=25 patients). Change from baseline in unanesthetized Schirmer’s test, inferior corneal fluorescein staining score (NEI Scale ranging from 0 to 4), conjunctival hyperemia assessment (0 to 4 scale), tear film breakup time (TFBUT) and eye dryness symptom (on a visual analog scale ranging from 0 to 100) were evaluated as effectiveness endpoints at each visit. Safety was evaluated via treatment-emergent adverse events (TEAEs).

Results : iLIEF was retained at Week 6 and Week 12, in 98% and 74% of eyes, respectively. Removability at Week 6 was 100%. Eye dryness symptom score improved after iLIEF insertion, baseline: 74.7 ± 6.0, change from baseline: -46.6 ± 24.2 (Week 6), -55.4 ± 15.9 (Week 12). Inferior corneal staining score improved, baseline: 2.0 ± 0.1, change from baseline: -0.9 ± 0.4 (Week 6), -0.9 ± 0.2 (Week 12). TFBUT improved, baseline: 7.47 ± 2.38 sec; change from baseline: +2.05 ± 4.68 sec (Week 6), +0.75 ± 3.22 sec (Week 12). Schirmer’s score improved for patients with baseline ≤10 mm/5min, baseline: 5.3 ± 2.9 mm; change from baseline: 2.0 ± 8.1 mm (Week 6), 3.2 ± 5.2 mm (Week 12). There were no reported TEAEs.

Conclusions : The iLIEF Canalicular Insert provided clinically significant reductions in signs and symptoms of dry eye and warrants further clinical evaluation as a treatment for the signs and symptoms of dry eye disease.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.