GlaucomaPhase 1TING1NCT05206877
Topical Insulin for Glaucoma
A Phase 1 study testing Insulin, 4 units, Insulin, 20 units and insulin, 4 units twice daily in people with Glaucoma, run by Stanford University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Insulin, 4 units, Insulin, 20 units and insulin, 4 units twice daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 31 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Study Team, glaucomatrials@stanford.edu
About this study
Official title: Topical Insulin for Glaucoma and Optic Neuropathies
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).
- Conditions
- Glaucoma
- Being tested
- Insulin, 4 units, Insulin, 20 units, insulin, 4 units twice daily, insulin, 20 units twice daily, insulin, 4 units three times daily
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin, 4 unitsDrug
Topical insulin 100 U/ml, 1 drop per day
Insulin, 20 unitsDrug
Topical insulin 500 U/ml, 1 drop per day
insulin, 4 units twice dailyDrug
1 drop of low dose insulin twice daily.
insulin, 20 units twice dailyDrug
1 drop of high dose insulin twice daily
insulin, 4 units three times dailyDrug
1 drop of low dose insulin three times daily.
insulin, 20 units three times dailyDrug
1 drop of high dose insulin three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Low dose topical insulin | Experimental | Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days Receives: Drug: Insulin, 4 units |
| High dose topical insulin | Experimental | Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days Receives: Drug: Insulin, 20 units |
| Longer-term topical insulin | Experimental | Group 3 randomized; N=20: 10 subjects will receive the highest tolerated dose (e.g. from group 1 or group 2), 1 drop per day at home for 1 month, full testing pre- and post-treatment, and 10 subjects will receive 1/5 of the highest tolerated dose (either the lower dose, or if needed will dilute) 1 drop per day at home for 1 month, full testing pre- and post-treatment. Receives: Drug: Insulin, 4 units; Drug: Insulin, 20 units |
| Low-Dose Insulin twice Daily | Experimental | Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days. Receives: Drug: insulin, 4 units twice daily |
| High-Dose Insulin twice Daily | Experimental | Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days. Receives: Drug: insulin, 20 units twice daily |
| Low-Dose Insulin three times daily | Experimental | Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days. Receives: Drug: insulin, 4 units three times daily |
| High-Dose Insulin three times daily | Experimental | Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days. Receives: Drug: insulin, 20 units three times daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events
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.
Measured: During treatment period, difference from baseline to post-treatment up to 2 months
Secondary outcomes (2)
Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)
The change in retinal thickness as measured by spectral domain optical coherence tomography (sdOCT)
Measured: During treatment period, difference from baseline to post-treatment up to 2 months
The change in visual field as measured by mean deviation
The change in visual field as measured by mean deviation on Zeiss Humphrey Visual Field testing
Measured: During treatment period, difference from baseline to post-treatment up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
- Investigators
- Jeffrey L Goldberg, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206877
- Sponsor's protocol ID
- 63337
- Acronym
- TING1
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share individual participant data