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

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.

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Glaucoma; Open Angle Glaucoma
• Intervention / Treatment: Device: Nanodropper

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mari Costantini; Phone Number: 415-353-2289; Email: Mari.Costantini@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Mari Costantini; Phone Number: 415-353-2289; Email: Mari.Costantini@ucsf.edu
      • Principal Investigator: Julius Oatts, MD
      • Sub-Investigator: Ying Han, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Nanodropper; Device to apply liquid medication to eyes
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Icare Finland Oy; Nanodropper, Inc.
• Investigators: Principal Investigator: Julius Oatts, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: 20-32530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results after deidentification(text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes