Comparative clinical study of eyedrops with nanoemulsion containing insulin or cannabidiol for the treatment of ocular damage caused by dry eye diseases.

• Grant number: 22/12312-6
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): January 01, 2023
• Effective date (End): December 31, 2023
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Eduardo Melani Rocha
• Grantee: Mateus Maia Marzola
• Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

Topical treatment of ocular surface diseases associated with dryness is still based on the principles of lubrication and anti-inflammation with corticosteroids and cyclosporine, as in cases of Sjogren's Syndrome, whose effectiveness is limited. New pharmacotechnical technologies can overcome the problems of bioavailability and therapeutic efficacy. Nanoemulsion drug delivery systems can be used as potential drug carriers for the treatment of dry eye and ocular surface diseases, such as insulin and cannabidiol. Because cannabidiol is shown to be effective in animals to reduce ocular sensitivity and insulin as a promoter of exocrine secretion, and both in preserving corneal integrity and lessening inflammation in response to chemical aggression.The study will be a single-center, phase I/II, randomized, double-masked, placebo-controlled trial. The clinical study will evaluate the safety and efficacy of eye drops containing insulin or cannabidiol in the treatment of pain and epitheliopathy associated with dry eye, compared to placebo. The study population (20 subjects per group) will consist of subjects with dry eye conditions indicated by continued use of tears in the last four months, baseline tearing d 5 mm by Schirmer's Test, or corneal fluorescein staining e 5 in at least one of the eyes. Volunteers will be evaluated for 3 weeks using one of the eye drops or placebo three times a day.Ocular signs and symptoms will be compared between groups in pre- and post-treatment conditions with insulin, cannabidiol, or placebo (vehicle), using the OSDI (Ocular surface disease index) questionnaire for changes in the ocular surface, the evaluation of the rupture time of the tear film (TRFL), corneal staining test with fluoroscein eye drops, conjunctival staining with topical lissamine green (1%) and the Schirmer test.The Scientific Initiation student will have the following functions: data collection and application of questionnaires; statistical analysis; the presentation of results in scientific events; and writing the manuscript.