Trials / Completed
CompletedNCT05181046
Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Glaucoma Patients
Non-inferiority of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Patients With Open-angle Glaucoma or Ocular Hypertension
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 420 (actual)
- Sponsor
- Nanodropper, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This randomized, single-masked, parallel study aims to evaluate the safety and efficacy of microdrops of 0.5% timolol maleate administered with Nanodropper (experimental intervention) compared to standard drops of 0.5% timolol maleate (active comparator) in patients with primary open-angle glaucoma (OAG) or ocular hypertension (OHT) at Aravind Eye Hospital. At the beginning of the test day, baseline (pre-drug) intraocular pressure (IOP), resting heart rate (HR), and resting systolic and diastolic blood pressure (BP) measurements will be collected. Participants will be randomized to receive standard eyedrops or microdrops of 0.5% timolol maleate (one drop per eye), which will be administered by a trained technician at t = 0. IOP, HR, and BP measurements will be repeated by a masked investigator at t = 1, 2, 5, and 8 hours after drug administration.
Conditions
- Glaucoma
- Glaucoma, Open-Angle
- Glaucoma, Primary Open Angle
- Glaucoma and Ocular Hypertension
- Ocular Hypertension
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-11-06
- Primary completion
- 2022-12-19
- Completion
- 2022-12-19
- First posted
- 2022-01-06
- Last updated
- 2023-01-18
Locations
2 sites across 1 country: India
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05181046. Inclusion in this directory is not an endorsement.