Trial results for a study evaluating the Nanodropper device for Glaucoma were posted on ClinicalTrials.gov on 2026-03-05. The trial was terminated after enrolling 16 participants.
Background
Glaucoma is the leading cause of irreversible blindness worldwide. Effective management often involves eye drops to lower intraocular pressure (IOP). The development of devices like the Nanodropper aims to deliver smaller, potentially more efficient eye drops. Previous research has indicated that smaller eye drops can be as effective as larger ones in treating glaucoma, suggesting a potential benefit in reducing waste or improving delivery. This study aimed to assess if the Nanodropper device could achieve non-inferiority in lowering IOP compared to standard of care eye drops.
Trial design
This terminated study, designated as Phase NA, enrolled 16 participants. The trial investigated the efficacy of the Nanodropper device in patients with Glaucoma, Ocular Hypertension, and Open Angle Glaucoma. The study compared the use of the Nanodropper to standard of care eye drops, with the objective of demonstrating non-inferiority in lowering intraocular pressure (IOP). No specific primary outcome measures were listed in the posted results.
Key results
The trial reported several key measurements for intraocular pressure (IOP):
- Intraocular Pressure (IOP) at Baseline:
- For the Nanodropper group, mean IOP was 21.1 mmHg (Standard Deviation 4.0).
- For the Standard of Care Dropper group, mean IOP was 18.4 mmHg (Standard Deviation 4.5).
- For the Nanodropper group, mean IOP was 20.1 mmHg (Standard Deviation 3.6).
- For the Standard of Care Dropper group, mean IOP was 19.3 mmHg (Standard Deviation 5.9).
- For the Nanodropper group, mean IOP was 21.3 mmHg (Standard Deviation 4.1).
- For the Standard of Care Dropper group, mean IOP was 20.1 mmHg (Standard Deviation 7.2).
- For the Nanodropper group, mean IOP was 22.6 mmHg (Standard Deviation 4.3).
- For the Standard of Care Dropper group, mean IOP was 20.6 mmHg (Standard Deviation 6.9).
- Intraocular Pressure (IOP) at Month 1:
- For the Nanodropper group, mean IOP was 17.4 mmHg (Standard Deviation 3.7).
- For the Standard of Care Dropper group, mean IOP was 16.5 mmHg (Standard Deviation 4.8).
- For the Nanodropper group, mean IOP was 16.9 mmHg (Standard Deviation 2.8).
- For the Standard of Care Dropper group, mean IOP was 16.8 mmHg (Standard Deviation 4.3).
What this means
The termination of this trial with a small enrollment of 16 participants limits the conclusions that can be drawn regarding the efficacy of the Nanodropper device for glaucoma. While mean intraocular pressure measurements at baseline and Month 1 were reported for both the Nanodropper and standard of care groups, no comparative analyses or statistical significance values were provided. Therefore, it is not possible to determine if the Nanodropper device achieved non-inferiority in lowering IOP based on these posted results. The available data provides preliminary observations on IOP changes over one month in a limited patient population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05273385, titled "Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma", were posted on 2026-03-05 on clinicaltrials.gov.