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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2024-12-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma Ocular Hypertension Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study personnel who will evaluate the IOP and economic endpoints will be blinded to patients' assigned dispenser types for the duration of the study.

Study Groups

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Nanodropper

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.

Group Type EXPERIMENTAL

Nanodropper

Intervention Type DEVICE

Device to apply liquid medication to eyes

Standard of Care Dropper

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nanodropper

Device to apply liquid medication to eyes

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No