Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin

Pharmaceuticals · 10 authors, 5 centres

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TL;DR

A phase I/II randomized controlled crossover trial evaluated a topical formulation containing helenalin from Arnica montana and hyaluronic acid 0.4% in patients with mild-to-moderate dry eye disease over 1 month. The formulation significantly improved tear film stability, tear secretion, ocular surface inflammation markers, and conjunctival morphology compared to control, with no serious adverse events reported.

Full summary

525 CHARS

This phase I/II study assessed the safety and efficacy of a topical formulation containing helenalin from Arnica montana L. combined with hyaluronic acid 0.4% in patients with mild-to-moderate DED. The formulation group showed statistically significant improvements from baseline in OSDI, NI-BUT, NIAvg-BUT, Schirmer's test, and meibomiography at 1 month. The control group did not show significant improvements in most parameters. Crossover analysis provided mechanistic evidence of time-dependent anti-inflammatory effects.

STUDY TYPE

other

SPECIALTY

ophthalmology

SUMMARISED BY

AI pipeline

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100% · A

ORIGINAL PAPER

PMC10892869

Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin

Pharmaceuticals

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ABSTRACT

Abstract The aim of this work was to assess the tolerability, safety, and efficacy of an ophthalmic topical formulation containing helenalin from Arnica montana and hyaluronic acid 0.4% (HA) in patients with mild-to-moderate Dry Eye Disease (DED) exhibiting positive Matrix Metalloproteinase 9 (MMP-9) test results. Tolerability and safety were evaluated in 24 healthy subjects. Participants were instructed to apply one drop of the formulation three times a day in the study eye, for 2 weeks, followed by a clinical follow-up of 21 days. Efficacy was studied in 48 DED patients randomized into Study (Group 1/receiving the studied formulation) or Control (Group 2/Receiving HA 0.4% eye lubricant) groups for 1 month. Assessments included an MMP-9 positivity test, conjunctival impression cytology (CIC), Ocular Surface Disease Index (OSDI), non-invasive film tear breakup time (NIBUT), non-invasive average breakup time (NIAvg-BUT), ocular surface staining, Schirmer’s test, and meibomiography. A crossover design with an additional 1-month follow-up was applied to both groups. Healthy subjects receiving the studied formulation exhibited good tolerability and no adverse events. Regarding the efficacy study, Group 1 exhibited a statistically significant reduction in the MMP-9 positivity rate compared to Group 2 ( p < 0.001). Both Group 1 and Group 2 exhibited substantial improvements in OSDI and NIBUT scores ( p < 0.001). However, Group 1 demonstrated a significant improvement in NI-Avg-BUT and Schirmer’s test scores ( p < 0.001), whereas Group 2 did not ( p > 0.05). Finally, after the crossover, the proportion of MMP-9-positive subjects in Group 1 increased from 25% to 91.6%, while Group 2 showed a significant decrease from 87.5% to 20.8%. Overall, the topical formulation containing sesquiterpene helenalin from Arnica montana and hyaluronic acid was well tolerated and exhibited a favorable safety profile. Our formulation reduces DED symptomatology and modulates the ocular surface inflammatory process; this is evidenced by the enhancement of CIC, the improvement of DED-related tear film status, and the reduction of the MMP-9 positivity rate. Keywords: ocular tolerability, Arnica , MMP-9, conjunctival impression cytology, meibomiography

CITATION EXPORT

Dalia Ng, Juan Carlos Altamirano-Vallejo, Jose Navarro-Partida et al.. Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin. Pharmaceuticals. (2024). https://doi.org/10.3390/ph17020175

AUTHORS

10 · 5 CENTRES

Dalia Ng, Juan Carlos Altamirano-Vallejo, Jose Navarro-Partida, Oscar Eduardo Sanchez-Aguilar, Andres Inzunza, Jorge Eugenio Valdez-Garcia, Alejandro Gonzalez-de-la-Rosa, Andres Bustamante-Arias, Juan Armendariz-Borunda, Arturo Santos

1Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Monterrey 64849, Nuevo Leon, Mexico; [email protected] (D.N.); [email protected] (J.C.A.-V.); [email protected] (J.N.-P.); [email protected] (O.E.S.-A.); [email protected] (A.I.); [email protected] (J.E.V.-G.); [email protected] (A.G.-d.-l.-R.); [email protected] (J.A.-B.)
2Grupo Oftalmologico Acosta, Hospital Puerta de Hierro, Zapopan 45116, Jalisco, Mexico
3Centro de Retina Medica y Quirurgica, Hospital Puerta de Hierro, Zapopan 45116, Jalisco, Mexico
4Clinica de Oftalmologia Sandiego, Medellin 050012, Colombia; [email protected]
5Centro Universitario Ciencias de la Salud, Universidad de Guadalajara, Guadalajara 44340, Jalisco, Mexico