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NCT Number: NCT05206877

Topical Insulin for Glaucoma

The purpose of this Phase 1 trial is to determine the safety over 1-2 months of topic sterile human recombinant insulin on subjects with optic neuropathies (glaucoma, ischecmic optic neuropathy, and optic disc drusen).

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location status: Recruiting

Location contact

Zac Wennberg-Smith

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Capable to provide informed consent
  • Diagnosis of optic neuropathy either glaucoma or NAION or optic disc drusen.
  • Only one eye per patient will be selected as the study eye - if both eyes meet the inclusion criteria, the eye with the worse acuity and /or visual field will be selected. The contralateral eye will be left untouched.

Exclusion criteria

  • Pregnant or breastfeeding woman
  • Presence of any ocular pathologies other than glaucoma that contributes to the severe vision loss (retinopathy / maculopathy, severe uveitis, keratopathy, etc.)
  • Diagnosis of glucose intolerance, type 1 or 2 diabetes mellitus
  • Inability to perform reliable visual field
  • Unable to provide informed consent
  • Unable to complete the tests and follow-ups required by the study

Treatment and study plan

Insulin, 4 units

Drug

Topical insulin 100 U/ml, 1 drop per day

Insulin, 20 units

Drug

Topical insulin 500 U/ml, 1 drop per day

insulin, 4 units twice daily

Drug

1 drop of low dose insulin twice daily.

insulin, 20 units twice daily

Drug

1 drop of high dose insulin twice daily

insulin, 4 units three times daily

Drug

1 drop of low dose insulin three times daily.

insulin, 20 units three times daily

Drug

1 drop of high dose insulin three times daily.

Primary outcomes

  1. Number of Participants with Treatment-Related Adverse Events

    Time frame: During treatment period, difference from baseline to post-treatment up to 2 months

    determine the safety of topical sterile human insulin in patients with optic neuropathies. AEs and SAEs will be monitored and recorded through the duration of the study.

Secondary outcomes

  1. Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)

    Time frame: During treatment period, difference from baseline to post-treatment up to 2 months

    The change in retinal thickness as measured by spectral domain optical coherence tomography (sdOCT)

  2. The change in visual field as measured by mean deviation

    Time frame: During treatment period, difference from baseline to post-treatment up to 2 months

    The change in visual field as measured by mean deviation on Zeiss Humphrey Visual Field testing

Study contacts

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

Mariana Nunez, MD

CONTACT

[email protected]

650-497-7846

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Topical Insulin for Glaucoma and Optic Neuropathies

Acronym: TING1

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2022
Registry last updated
Nov 25, 2025

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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