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

NCT05273385 | Terminated Results DMC FDA Device

• 1 other identifier: 20-32530
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Ocular Hypertension; Open Angle Glaucoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Survey

  3 months

• Conjunctival Grading at Baseline

  At baseline

• Conjunctival Grading at Month 3

  3 months

Study Arms (2)

Nanodropper

EXPERIMENTAL

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

Standard of Care Dropper

NO INTERVENTION

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.

Interventions

Nanodropper DEVICE

Device to apply liquid medication to eyes

Nanodropper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Icare Finland Oy: collaborator
• University of California, San Francisco: lead
• Nanodropper, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

This study was terminated due to low enrollment numbers.

Results Point of Contact

• Title: Ying Han
• Organization: UCSF

ying.han@ucsf.edu

415-353-2020

Study Officials

• Julius Oatts, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study personnel who will evaluate the IOP and economic endpoints will be blinded to patients' assigned dispenser types for the duration of the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: October 10, 2022
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: March 5, 2026
• Results First Posted: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)