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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Insulin for Glaucoma and Optic Neuropathies
- ClinicalTrials.gov ID
- NCT05206877
- Acronym / sponsor ID
- TING1 / 63337
- Conditions
- Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Low dose topical insulin | Experimental | Drug: Insulin, 4 unitsGroup 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days |
| High dose topical insulin | Experimental | Drug: Insulin, 20 unitsGroup 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days |
| Longer-term topical insulin | Experimental | Drug: Insulin, 4 units, Drug: Insulin, 20 unitsGroup 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. |
| Low-Dose Insulin twice Daily | Experimental | Drug: insulin, 4 units twice dailyGroup 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days. |
| High-Dose Insulin twice Daily | Experimental | Drug: insulin, 20 units twice dailyGroup 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days. |
| Low-Dose Insulin three times daily | Experimental | Drug: insulin, 4 units three times dailyGroup 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days. |
| High-Dose Insulin three times daily | Experimental | Drug: insulin, 20 units three times dailyGroup 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin, 4 unitsTopical insulin 100 U/ml, 1 drop per day | Drug | Longer-term topical insulin, Low dose topical insulin |
| Insulin, 20 unitsTopical insulin 500 U/ml, 1 drop per day | Drug | High dose topical insulin, Longer-term topical insulin |
| insulin, 4 units twice daily1 drop of low dose insulin twice daily. | Drug | Low-Dose Insulin twice Daily |
| insulin, 20 units twice daily1 drop of high dose insulin twice daily | Drug | High-Dose Insulin twice Daily |
| insulin, 4 units three times daily1 drop of low dose insulin three times daily. | Drug | Low-Dose Insulin three times daily |
| insulin, 20 units three times daily1 drop of high dose insulin three times daily. | Drug | High-Dose Insulin three times daily |
Primary outcome
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.
2 secondary outcomes
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 visual field as measured by mean deviation
Time frame: During treatment period, difference from baseline to post-treatment up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. No current plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey L Goldberg, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Team (650-497-5942, glaucomatrials@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events (time frame: During treatment period, difference from baseline to post-treatment up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.