Efficacy of a Novel Integrated Active Herbal Formulation in Experimentally Induced Rat Model for Dry Eye Disease

Abstract

Abstract Objectives Dry eye is common condition of eye with insufficient production of tears leading to inadequate lubrication of eyes. It is chronic in nature & may be associated with discomfort & eye redness, blurred vision & tear film instability leading to potentially damaged ocular surfaces. Inflammation & oxidative stress play significant role in pathogenesis of disease by causing ocular surface disruption. Traditional Rx for dry eyes such as artificial tears, punctual plugs, prescription eye drops, etc. doesn't adequately address underlying causes of dry eyes. Further many of treatments are in form of eye drops that require regular administration to eyes, which is inconvenient & contains preservatives that further irritate eyes. We evaluated integrated active formulation administered orally to alleviate symptoms of dry eyes in rat model. Methods We used proprietary formulation technology to blend multiple ingredients into an integrated oil suspension (OS) that can be conveniently used in an oral dosage form. Ingredients included bioavailable form of Curcumin, Lutein/Zeaxanthin (L/Z) and Vit D3 formulated as an integrated product. Dry eye condition was created by administration of BAK (benzalkonium chloride) to eyes of female Wistar rat twice daily for 14 days, followed by initiation of supplementation by administering integrated dry eye formulation by oral gavage for 4 weeks at dose of 100 & 200 mg/kg b.w. to evaluate effect of this novel formulation. 7 rats were included in each group. Results There was significant improvement in tear volume, tear breakup time, tear film integrity & reduced overall inflammation, histopathological examination with supplementation. Our formulation helped in lowering oxidative stress as evidenced by significant reduced serum & corneal MDA, increased corneal SOD & corneal GPx. Levels of inflammatory cytokines such as NF-κB, TNF-α, IL-1β, IL-6 & IL-8 were significantly reduced & protective proteins such as MUC1, MUC4, MUC5AC and MMP-9 were restored by supplementation with integrated dry eye formulation which were otherwise lowered in dry eye condition. Conclusions Our results strongly suggest that our novel integrated active formulation of Curcumin, L/Z, Vit D3 is effective in alleviating symptoms of dry eye condition with multi-modal mechanism of action in dose dependent manner. Funding Sources OmniActive Health Technologies Limited.