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Hormone Therapy

Topical Insulin Drops for Glaucoma

Phase 1
Recruiting
Led By Qianqian Wang, MD, FRCSC
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable to provide informed consent
Age 18-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will study the safety of using insulin to treat glaucoma.

Who is the study for?
This trial is for adults aged 18-75 with moderate primary open-angle glaucoma, who can consent and have a specific range of eye damage. They must not be diabetic, malnourished, or have conditions affecting potassium levels. Pregnant women and those with recent eye surgery are excluded.Check my eligibility
What is being tested?
The study tests the safety of daily topical insulin drops (up to 500 U/ml) in patients with open-angle glaucoma to see if it's safe compared to artificial tears. It explores whether insulin can help protect and regenerate nerve cells in the eye.See study design
What are the potential side effects?
While systemic insulin use can cause low blood sugar, potassium issues, allergies, weight gain, swelling and other effects; previous small studies suggest that topical ocular insulin may not have significant adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to understand and agree to the study's procedures and risks.
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I am between 18 and 75 years old.
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I have been diagnosed with moderate open-angle glaucoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ocular tolerability of the instilled drops
Rate of hypoglycemia
Hypokalemia
+1 more
Secondary outcome measures
Average RNFL and GCC thickness on SD-OCT
Flow index (FI) on OCT-Angiography (OCT-A)
Intraocular pressure (IOP)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical insulinExperimental Treatment2 Interventions
Patients will receive topical insulin eye drops.
Group II: Topical artificial tearsPlacebo Group1 Intervention
Patients will receive topical artificial tears.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,619 Total Patients Enrolled
7 Trials studying Glaucoma
452 Patients Enrolled for Glaucoma
Qianqian Wang, MD, FRCSCPrincipal InvestigatorDépartement d'ophtalmologie, Centre hospitalier de l'Université de Montréal

Media Library

Topical Insulin Drops (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04118920 — Phase 1
Glaucoma Research Study Groups: Topical insulin, Topical artificial tears
Glaucoma Clinical Trial 2023: Topical Insulin Drops Highlights & Side Effects. Trial Name: NCT04118920 — Phase 1
Topical Insulin Drops (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04118920 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant population size of this experiment?

"This medical trial is not presently accepting applications. It was first posted on February 1st 2023, with the last update occurring November 29th 2022. For those looking to join a clinical study, there are 215 research trials for glaucoma and 72 studies recruiting candidates for Topical insulin available right now."

Answered by AI

Are there available slots to join this investigation?

"Data on clinicaltrials.gov attests that this particular trial is not presently accepting new applicants. Initially posted on February 1st 2023, the most recent update was made in November of 2022. Despite its lack of recruitment at present time, there are still 287 other medical studies actively enrolling patients."

Answered by AI

Has Topical insulin been investigated in any other research endeavors?

"Presently, there are 72 active Topical insulin trials with 13 at Phase 3. Most of the studies for this substance take place in Sao Luis, MA; however, a total of 248 clinical trial sites have included research on topical insulin."

Answered by AI

What potential risks exist when using topical insulin treatments?

"Due to the limited success of prior clinical trials, Topical insulin is estimated to be relatively unsafe on a scale from 1-3. This medical trial being classified as Phase 1 implies there has been little data supporting its efficacy or safety."

Answered by AI

What is the main aim of this clinical trial?

"Over the course of a 12 month period, this trial will track Rate of Hypoglycemia as its primary outcome. Furthermore, it will also measure P50-N95 amplitude on PERG; PERG P50 implicit time; and Snellen chart visual acuity expressed in logMAR to establish secondary outcomes."

Answered by AI
~9 spots leftby Apr 2025