Status:
UNKNOWN
Use of Nanodropper vs. Standard Eyedropper in Patients With Glaucoma and Ocular Hypertension
Lead Sponsor:
University of Washington
Conditions:
Glaucoma, Open-Angle
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and usability of an eyedrop bottle adaptor that creates smaller eyedrops, Nanodropper, in an open-angle glaucoma/ocular hypertension pati...
Detailed Description
This 6-month prospective, randomized, single-masked, active-controlled, crossover (AB:BA) study aims to evaluate the safety, efficacy, and usability of Nanodropper-mediated microdrops of IOP-lowering ...
Eligibility Criteria
Inclusion
- ≥18 years old
- Primary open-angle glaucoma (OAG) diagnosis
- Ocular hypertension (OHT) diagnosis
- Corneal thickness \<600 µm
- Use 1-2 IOP-lowering eyedrop medications that are compatible with Nanodropper
- OAG/OHT must be well-controlled (defined as ≥2 IOP measurements collected within 6 months of recruitment that are ≤21 mm Hg with variability of ±3 mm Hg)
- OAG/OHT must be progression-free (as judged by the clinician and based on ≥2 stable OCT and visual field tests collected in the 6 months prior to recruitment)
Exclusion
- Uncontrolled glaucoma (IOP \>21 mmHg)
- Use of \>2 medications for treatment of OAG/OHT
- Use of eyedrop medications that are incompatible with Nanodropper
- OAG/OHT progression (as judged by the clinician within the past 6 months)
- Eye surgery including laser procedures (e.g., SLT, iridotomy) within 6 months of recruitment
- Diagnosis of acute angle-closure glaucoma and/or other retinal diseases
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05277870
Start Date
February 28 2022
End Date
June 30 2025
Last Update
March 14 2022
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98104