Comparing a new eyedropper to a standard one for glaucoma treatment
Use of Nanodropper vs. Standard Eyedropper in Patients With Glaucoma and Ocular Hypertension
This study is testing a new eyedropper that makes smaller drops to see if it helps people with glaucoma and high eye pressure better than the standard eyedropper.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05277870 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, efficacy, and usability of the Nanodropper, an eyedrop bottle adaptor that produces smaller drops, in patients with open-angle glaucoma and ocular hypertension. It is a 6-month, prospective, randomized, single-masked, active-controlled, crossover study conducted at Harborview Eye Institute. Participants will be randomly assigned to receive either standard eyedrops or Nanodropper-mediated microdrops for three months before switching to the other treatment. The study includes three clinic visits for assessments and education on proper eyedrop administration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with well-controlled primary open-angle glaucoma or ocular hypertension using 1-2 compatible IOP-lowering medications.
Not a fit: Patients with uncontrolled glaucoma, those using more than two medications, or those with recent eye surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve medication adherence and reduce side effects for patients with glaucoma and ocular hypertension.
How similar studies have performed: Other studies have shown promise in using smaller eyedrops for improved outcomes, making this approach a potentially valuable advancement.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥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 Criteria: * 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
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Raghu Mudumbai — University of Washington
- Study coordinator: Simona Vuletic
- Email: simona@uw.edu
- Phone: 206-520-9728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.