Expert opinion on drug delivery · 2026
Preclinical and clinical evaluation of an ocular nanoemulsion for the treatment of dry eye disease.
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Vukelić Karina, Pejaković Tajana Iva, Krivičić Hyrat Blanka, Vukelić Obad Mia, Knežević Zdravka, Degirmenci Cumali, Ahmadli Emil, Palamar Onay Melis, Gökçe Evren Homan, Tanrıverdi Sakine Tuncay, Ozer Özgen
Аннотация
BACKGROUND: 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.
RESEARCH DESIGN AND METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION: Clinical trial registration: www.clinicaltrials.gov identifier is NCT06323395.
RESEARCH DESIGN AND METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
TRIAL REGISTRATION: Clinical trial registration: www.clinicaltrials.gov identifier is NCT06323395.