Drug delivery systems through eye drops for the treatment of Dry Eye symptoms

Phase 1

Recruiting

• Conditions: Sjogren' s Syndrome; C11.496.260

• Registration Number: RBR-7p43fkc
• Lead Sponsor: Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-16
• Study Completion: 2023-10-31
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified