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

Not Applicable

Recruiting

• Conditions: Glaucoma; Ocular Hypertension; Open Angle Glaucoma
• Interventions: Device: Nanodropper

• Registration Number: NCT05273385
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Study Start: 2022-10-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanodropper	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.

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP) at Month 3	3 months	IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Intraocular pressure (IOP) at Baseline	At Baseline	IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Intraocular pressure (IOP) at Month 1	1 month	IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer.

Secondary Outcome Measures

Name	Time	Method
Conjunctival Grading at Month 3	3 months	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.
Survey	3 months	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)
Conjunctival Grading at Baseline	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States