Authors
Karina Vukelić, Tajana Iva Pejaković, Blanka Krivičić Hyrat, Mia Vukelić Obad, Zdravka Knežević, Cumali Degirmenci, Emil Ahmadli, Melis Palamar Onay, Evren Homan Gökçe, Sakine Tuncay Tanrıverdi, Özgen Ozer
Published in
Expert opinion on drug delivery. Oct 06, 2026. Epub Oct 06, 2026.
Abstract
The efficacy, safety, and ocular retention of a novel preservative-free nanoemulsion eye drop formulation (VSLB) containing castor oil and sodium hyaluronate for dry eye disease (DED) were evaluated.
A preclinical evaluation using a scopolamine-induced dry eye rat model and a prospective, randomized, double-masked clinical study involving 64 human subjects with moderate-to-severe DED were conducted. Tear film breakup time (TFBUT), ocular surface disease index (OSDI), Meibomian gland assessment, and pre-ocular residence time were measured.
VSLB significantly improved TFBUT from <2 seconds on day 2 to 10.83 ± 1.5 seconds at day 28, comparable to marketed product and healthy controls in rats. Ocular residence time for VSLB remained detectable in 3 out of 6 animals, compared to 0 in placebo.In the clinical phase, mean TFBUT in the VSLB group increased from 4.26 ± 2.14 s (baseline) to 6.36 ± 2.73 s at day 15 and 6.00 ± 2.93 s at day 30. The OSDI score and the Meibomian gland expressibility score and secretion quality were also improved. No serious adverse events were reported.
VSLB demonstrated a promising therapeutic profile by tear-film stabilization and symptomatic relief. Its preservative-free, lipid-enhancing formulation with prolonged ocular residence suggests a safe and effective treatment option for DED.
Clinical trial registration: www.clinicaltrials.gov identifier is NCT06323395.
PMID:
42837491
Bibliographic data and abstract were imported from PubMed on 07 Oct 2026.
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