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
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
- Glaucoma
- Glaucoma, Open-Angle
- Glaucoma, Primary Open Angle
- Glaucoma and Ocular Hypertension
- Ocular Hypertension
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
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