Topical Insulin for Glaucoma (TING2)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.
• 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.
• 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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Oct 31, 2028

Completion

Oct 31, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Low-Dose EYED-002
  N=5 participants with open-angle glaucoma. Low-dose topical insulin (EYED-002), administered as one drop to the study eye once daily in-clinic for 5 consecutive days. Open-label.
• Experimental: Group 2: High-Dose EYED-002
  N=5 participants with open-angle glaucoma. High-dose topical insulin (EYED-002), administered as one drop to the study eye once daily in-clinic for 5 consecutive days.
• Experimental: Group 3: Active EYED-002 (Randomized)
  N=40 participants randomized to active EYED-002 at the highest tolerated dose from Groups 1 or 2, administered once daily at home for 12 months. Double -masked.
• Placebo Comparator: Group 3: Vehicle Placebo (Randomized)
  N=20 participants randomized to vehicle-only placebo, administered once daily at home for 12 months. double-masked. Eligible participants may roll over to open-label active EYED-002 for an additional 12 months after Month 12.
• Experimental: Group 4: Open-Label Access
  N=20 participants ineligible for randomization due to glaucoma severity. Receive highest tolerated dose of EYED-002 once daily for 12 months in an open-label access arm.

Primary Outcome Measure

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) ]

Central Contacts

• Study Team
  650-497-5942
  [email protected]

Locations (1)

Find similar trials in Palo Alto, CA

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