Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Glaucoma Patients

NCT05181046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2023-01-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of microdrops vs. standard eyedrops of 0.5% timolol maleate in adults with primary open-angle glaucoma or ocular hypertension in terms of intraocular pressure-lowering efficacy and cardiovascular side effects.

Conditions

Interventions

DEVICE

Nanodropper adaptor

The Nanodropper adaptor is a sterile medical device that reduces the size of administered eyedrops by coupling to the original bottle.

OTHER

Original eyedrop bottle/No Nanodropper

The original eyedrop bottle dispenses standard eyedrops.

Sponsors & Collaborators

  • Aravind Eye Care System

    collaborator OTHER
  • Nanodropper, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Steger, PhD · Nanodropper, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-06
Primary Completion
2022-12-19
Completion
2022-12-19
FDA Device
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181046 on ClinicalTrials.gov