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NCT Number: NCT07619482

Topical Insulin for Glaucoma (TING2)

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.

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Key information

Conditions

Open Angle Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Iris Diseases Low Tension Glaucoma Ocular Hypertension Optic Nerve Diseases Pigmentary Glaucoma Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Uveal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location contact

Jeffrey Goldberg, MD PhD

PRINCIPAL_INVESTIGATOR

Study Team

CONTACT

[email protected]

6504975942

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EYED-002 Low Dose (721 U/mL topical insulin)

Drug

Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye for duration of study group.

Other names: Topical Sterile Human Insulin

EYED-002 High Dose (1442 U/mL topical insulin)

Drug

Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye once daily in-clinic for duration of study group.

Other names: Topical Sterile Human Insulin

EYED-002 (highest tolerated dose, 12-month)

Drug

Highest tolerated dose of EYED-002 (721 U/mL or 1442 U/mL, determined from Groups 1 and 2 safety review). Once daily at home for 12 months in single-use vials, dispensed at quarterly visits.

Other names: Topical Sterile Human Insulin

Vehicle Placebo

Drug

Vehicle-only formulation without active insulin. Single-use vials identical in appearance to active EYED-002. Once daily at home for 12 months.

Other names: Placebo eye drop

Primary outcomes

  1. Incidence and severity of ocular and systemic adverse events (AEs) and serious adverse events (SAEs)

    Time frame: From informed consent through end of participation (up to 27 months)

    Safety of topical sterile human insulin (EYED-002) in patients with open-angle glaucoma. AEs and SAEs classified using MedDRA nomenclature, assessed for severity (mild, moderate, severe) and causality. Safety monitoring includes glycemia measurements before and 2 hours after in-clinic insulin administration, and serial serum electrolyte (potassium) measurements.

Secondary outcomes

  1. Change in retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness by SD-OCT

    Time frame: Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

    Change in retinal thickness as measured by spectral domain optical coherence tomography (SD-OCT).

  2. Change in visual field by Humphrey 24-2 (mean deviation, VFI, pointwise analysis)

    Time frame: Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

    Change in visual field as measured by mean deviation, visual field index, and pointwise analysis on Humphrey 24-2 testing.

  3. Change in best corrected visual acuity (BCVA) by ETDRS

    Time frame: Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

    Change in visual acuity as measured by ETDRS chart.

  4. Change in contrast sensitivity by FrACT contrast test

    Time frame: Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

    Change in contrast sensitivity as measured by the computer-based FrACT contrast test.

  5. Change in quality of life by GQL-15 questionnaire

    Time frame: Baseline, 6 months, and 12 months (Group 3)

    Change in patient-reported quality of life as measured by the Glaucoma Quality of Life-15 (GQL-15) questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team

CONTACT

[email protected]

650-497-5942

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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