Topical Insulin for Glaucoma (TING2)

A Phase 1/2 Dose Escalation Followed by a Masked, Randomized, Placebo-Controlled Study to Evaluate Topical Insulin for Neuroprotection in Open Angle Glaucoma

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.

Limited Inclusion Criteria - All Groups:

• 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
• Diagnosis of glaucoma
• Only one eye per patient will be selected as the study eye; if both eyes meet inclusion criteria, the eye with worse visual acuity and/or visual field will be selected

Limited Exclusion Criteria - All Groups:

• 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
• Unable to provide informed consent
• Unable to complete the tests and follow-ups required by the study