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Modulating Matrix Metalloproteinase-9 and Enhancing Ocular Surface Health in Dry Eye Disease Patients: A Clinical Evaluation of A Topical Formulation Containing Sesquiterpene Lactone Helenalin
Ng, D.; Altamirano-Vallejo, J.C.; Sanchez-Aguilar, O.E.; Inzunza, A.; Valdez-Garcia, J.E.; Gonzalez-de-la-Rosa, A.; Bustamante-Arias, A.; Armendáriz-Borunda, J.; Santos, A. Modulating Matrix Metalloproteinase-9 and Enhancing Ocular Surface Health in Dry Eye Disease Patients: A Clinical Evaluation of A Topical Formulation Containing Sesquiterpene Lactone Helenalin. Preprints2023, 2023091155. https://doi.org/10.20944/preprints202309.1155.v1
APA Style
Ng, D., Altamirano-Vallejo, J.C., Sanchez-Aguilar, O.E., Inzunza, A., Valdez-Garcia, J.E., Gonzalez-de-la-Rosa, A., Bustamante-Arias, A., Armendáriz-Borunda, J., & Santos, A. (2023). Modulating Matrix Metalloproteinase-9 and Enhancing Ocular Surface Health in Dry Eye Disease Patients: A Clinical Evaluation of A Topical Formulation Containing Sesquiterpene Lactone Helenalin. Preprints. https://doi.org/10.20944/preprints202309.1155.v1
Chicago/Turabian Style
Ng, D., Juan Armendáriz-Borunda and Arturo Santos. 2023 "Modulating Matrix Metalloproteinase-9 and Enhancing Ocular Surface Health in Dry Eye Disease Patients: A Clinical Evaluation of A Topical Formulation Containing Sesquiterpene Lactone Helenalin" Preprints. https://doi.org/10.20944/preprints202309.1155.v1
Abstract
Purpose: 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.
Methods: Tolerability and safety were evaluated in 24 healthy subjects. Participants were in-structed to routinely apply one drop of the formulation three times a day in the study eye, for a period of two weeks, followed by a clinical follow-up of 21 days. Efficacy was studied in 48 DED patients randomized into Study (Group 1/ receiving the study formulation) or Control (Group 2/ Receiving HA 0.4% eye lubricant) groups, for 4 weeks. Assessments included MMP-9 positivity, conjunctival impression cytology (CIC), Ocular Surface Disease Index (OSDI), non-invasive tear film breakup time (NIF-BUT), non-invasive average breakup time (NIAvg-BUT), ocular surface staining, Schirmer's test, and meibomiography. A crossover design with a four-week follow-up was applied to the control group.
Results: Healthy subjects receiving the study formulation exhibited good tolerability and no ad-verse events. Group 1 showed significant MMP-9 reduction (25% positivity rate) unlike Group 2 (87.5% positivity rate). Group 1 displayed improved CIC (33.3% vs. 0% SSD) compared to Group 2 (29.1%). OSDI and NIF-BUT scores improved in both groups (p < 0.001). Only Group 1 showed improved NIAvg-BUT and Schirmer’s test scores (p < 0.001), while Group 2 did not (p > 0.05). MMP-9-positive subjects shifted from 25% to 91.6% in Group 1 and 87.5% to 20.8% in Group 2 after the follow-up.
Conclusion: The topical formulation containing helenalin from Arnica montana and hyaluronic acid is well tolerated and has a good safety profile. Our formulation reduces DED sympto-matology and modulates the ocular surface inflammatory process; this is evidenced by the en-hancement of CIC, the improvement of DED-related tear film status, and the reduction of MMP-9 positivity rate.
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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