This study evaluates the safety and preliminary efficacy of topical sterile human insulin eye drops (EYED-002) in patients with open-angle glaucoma. The study uses a phase 1/2 dose-escalation design followed by a masked, randomized, placebo-controlled phase. Insulin is formulated as preservative-free eye drops and delivered once daily. The primary objective is to determine the safety profile of topical insulin; secondary objectives assess effects on retinal structure, visual field, visual acuity, contrast sensitivity, and quality of life.
Provide written informed consent approved by the appropriate ethics committee
Age 18 years or older
Understand study procedures and have the ability and willingness to abide by all procedures during the study
Capable of providing informed consent
Pregnant or breastfeeding
Presence of any ocular pathology other than glaucoma that contributes to severe vision loss (retinopathy, maculopathy, severe uveitis, keratopathy, etc.)
Diagnosis of glucose intolerance, type 1 or type 2 diabetes mellitus
Inability to perform reliable visual field testing