Compounded 0.03% Tacrolimus in Cross-Linked Hyaluronate Improves Ocular Surface Health in Dogs With Evaporative Dry Eye Disease.

Abstract

Objective: To assess the clinical effects of a compounded 0.03% tacrolimus in 0.75% cross-linked hyaluronic acid (XHA) on tear quantity, quality, and ocular surface health in dogs with evaporative dry eye disease (EDED).

Procedures: Sixteen client-owned dogs diagnosed with EDED (normal aqueous production yet reduced stability) were enrolled in this prospective, open-label clinical trial. Patients were treated with the compounded formulation in affected eyes twice daily for 45 days. Ophthalmic assessments, including Schirmer tear test-1 (STT-1), tear film breakup time (TFBUT), punctate fluorescein staining (PFS), lissamine green staining, and conjunctival hyperemia scoring, were performed during designated morning appointments at Day 0, Day 15, and Day 45. Data were analyzed using repeated-measures ANOVA and post hoc tests.

Results: STT-1 values increased significantly from 18.7 ± 2.3 mm/min at baseline to 21.7 ± 4.1 mm/min at Day 45 (p = 0.004). Tear film stability improved markedly, with TFBUT rising from 3.3 ± 0.7 s to 5.2 ± 1.4 s (Day 15) and 8.1 ± 2.4 s (Day 45) (p < 0.001). Ocular surface health improved, evidenced by PFS scores decreasing from 1.8 ± 0.9 to 0.3 ± 0.4 (p < 0.001) and lissamine green scores dropping from 1.9 ± 1.1 to 0.1 ± 0.3 (p < 0.001). Conjunctival hyperemia scores declined significantly by Day 45 (p = 0.041).

Conclusions: Twice-daily administration of compounded XHA/tacrolimus resulted in significant improvements in tear quantity, stability, and corneoconjunctival integrity. Combining immunomodulation with long-acting lubrication in a single formulation offers a promising, practical therapeutic strategy for efficiently managing canine qualitative dry eye disease in clinical practice.