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Topical Insulin for Glaucoma (TING2)

NCT07619482 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-06-02

No results posted yet for this study

Summary

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.

Conditions

  • Open Angle Glaucoma
  • Primary Open Angle Glaucoma
  • Low Tension Glaucoma
  • Pigmentary Glaucoma
  • Pseudoexfoliation Glaucoma

Interventions

DRUG

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

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

DRUG

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

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

DRUG

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

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.

DRUG

Vehicle Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Jeffrey L Goldberg, MD PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-10-31
Completion
2029-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619482 on ClinicalTrials.gov