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

Study Overview
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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.

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.

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

Conditions
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Glaucoma, Ocular Hypertension, Open Angle Glaucoma

Intervention / Treatment
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* Device: Nanodropper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) Use of prostaglandin analogue (PGA) eye drop Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months) Exclusion Criteria: Uncontrolled glaucoma Have had eye surgery (including laser procedures) within the past six months Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases Use of non-PGA class of IOP-lowering medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanodropper<br>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. | Device: Nanodropper<br>* Device to apply liquid medication to eyes<br>|
| No Intervention: Standard of Care Dropper<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 3 months | 

Secondary Outcome Measures

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