Sjogren's Syndrome
Conditions
Interventions
The study will be conducted at the Ophthalmology Division, External Ocular Diseases Department of the Hospital das Clínicas of Ribeirão Preto. The study will be a phase I/II clinical trial, randomized
D06.472.699.587.200.500.625.500
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The authors intend to include 60 participants, divided into three groups of 20 (Experimental Group I: insulin eye drops; Experimental Group II: cannabidiol eye drops; Placebo Group: eye drops without active ingredient). Subjects must meet all inclusion criteria to be eligible to participate in the study: subjects of any color and gender, over 18 years of age at the time of enrollment; read, understand, and sign the informed consent form; understand the study procedures and adhere to them throughout the study; have a history of dry eye, and have used tear-lubricating agents within the last 4 months; basal tear <5 mm; Corneal coloration 2 (NEI grading system, Lemp 1995) in at least one eye
Exclusion criteria
Exclusion criteria: Subjects who meet any of the exclusion criteria at visit 1 will be excluded from participation in the study: subjects who have any active infectious ocular conditions; individuals with inflammatory eye diseases (eg, conjunctivitis, keratitis, uveitis, or others) unrelated to dry eye; continued use of topical eye medications (including ocular cyclosporine and glaucoma medications) with the exception of artificial tears or lubricating ointments; taking medications that can cause dry eyes immediately prior to this study (Wong, Lan et al. 2011); any physical or mental disability that impedes participation and the ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy and safety of insulin- or cannabidiol-carrying nanoemulsions in the topical treatment of dry eye syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the improvement in ocular surface conditions between insulin and cannabidiol formulations. | — |
Countries
Brazil
Contacts
Public ContactEduardo Rocha
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed