Nanodropper for Glaucoma

Recruiting in Palo Alto (17 mi)

Overseen byAlexandra Papp, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: 59th Medical Wing

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new method of delivering smaller eye drops using a device called Nanodropper in patients with glaucoma and high eye pressure. The goal is to see if these smaller drops work as well as regular drops in lowering eye pressure, with potentially fewer side effects and better usability. Nano eye-drops are a new type of ophthalmic treatment with increased potency and reduced side effects.

Research Team

Alexandra Papp, MD

Principal Investigator

59th Medical Wing

Eligibility Criteria

This trial is for adults over 18 with primary open-angle glaucoma or ocular hypertension who are on up to two medications to lower eye pressure and have had stable disease for the past year. It's not for those whose condition worsened in the last year, on more than two meds, or who've had certain eye surgeries.

Inclusion Criteria

My eye condition has not worsened in the past year.

I am using up to 2 medications to lower my eye pressure.

I am over 18 and have glaucoma or high eye pressure.

Exclusion Criteria

My eye condition is not primary open-angle glaucoma or related to high eye pressure.

My eye condition has worsened in the last year.

I am using more than 2 medications to lower my eye pressure.

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Treatment Details

Interventions

Nanodropper (Device)
Regular dropper (Device)

Trial OverviewThe study tests if a Nanodropper, which gives smaller drops of medication, is as safe and effective as regular eyedroppers in delivering treatment for high eye pressure. Participants will try both methods at different times to compare results.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: NanodroperExperimental Treatment1 Intervention

* Patients are given a Nanodropper to use with their IOP-lowering eyedrops. * Patient returns for a safety check 1 month following the start of Nanodropper use. * At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops without Nanodropper for 3 months. * The patient returns at 6 months for final clinical assessment

Group II: Regular DropperActive Control1 Intervention

* Patient continues using current IOP-lowering eyedrops without Nanodropper adaptor. * At 3 months, the patient returns for clinical assessment and starts using IOP-lowering eyedrops with Nanodropper for 3 months. * Patient returns for a safety check 1 month following the start of Nanodropper use. * The patient returns at 6 months for final clinical assessment