Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Open Angle Glaucoma; Glaucoma; Ocular Hypertension

Treatments: Device: Nanodropper

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05273385

20-32530

Details and patient eligibility

About

Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.

Full description

The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial.

Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients.

Stable glaucoma participants and ocular hypertension participants of ages 18+ will be randomized to either use Nanodropper for eye drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 1 month and 3 months.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years old or older
2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT)
3. Use of prostaglandin analogue (PGA) eye drop
4. Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months)

Exclusion criteria

1. Uncontrolled glaucoma
2. Have had eye surgery (including laser procedures) within the past six months
3. Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases
4. Use of non-PGA class of IOP-lowering medication

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Nanodropper

Experimental group

Description:

Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.

Treatment:

Device: Nanodropper

Standard of Care Dropper

No Intervention group

Description:

Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.