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

University of California, San Francisco16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Glaucoma Ocular Hypertension Open Angle Glaucoma

Interventions

NanodropperDEVICE

Device to apply liquid medication to eyes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Intraocular Pressure (IOP) at Baseline

IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer.

Time frame: At Baseline

Intraocular Pressure (IOP) at Month 1

IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer.

Time frame: 1 month

Intraocular Pressure (IOP) at Month 3

IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer.

Time frame: 3 months

Secondary Outcomes

Survey

The following open-ended questions will be administered to participants randomized to the Nanodropper group at the end of the 3-month study. 1. Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no) 2. Did you find the Nanodropper easy to use? (yes/no) 3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no)

Time frame: 3 months

Conjunctival Grading at Baseline

Conjunctival grading will be performed by a masked ophthalmologist at the baseline study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome.

Time frame: At baseline

Conjunctival Grading at Month 3

Conjunctival grading will be performed by a masked ophthalmologist the 3 month study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness grading 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome.

Data from ClinicalTrials.gov

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