Glaucoma, Open-AngleNCT05277870
Use of Nanodropper vs. Standard Eyedropper in Patients With Glaucoma and Ocular Hypertension
A study testing Nanodropper adaptor in people with Glaucoma, Open-Angle and Ocular Hypertension, run by University of Washington at 1 site in United States.
Trial 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 patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Nanodropper adaptor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98104
Simona Vuletic, MD, 206-520-9728, simona@uw.edu
Brian Gomer, 206-520-9728, bgome001@uw.edu
About this study
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 patient population.
Read the 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 medications (experimental intervention) compared to standard eyedrops of the same medications (active comparator) in open-angle glaucoma or ocular hypertension patients at Harborview Eye Institute, for which permission has been obtained. A pre-study visit will be held before the start of the trial in which participant clinical histories will be documented and an ocular examination will be performed. Patients will be enrolled in the study by satisfying all the inclusion and none of the exclusion criteria. This 6-month study will include three clinic visits: a baseline visit at t = 0, crossover visit at t = 3 months, and final visit at t = 6 months. At the baseline visit, patients will be randomly assigned to one of two treatment groups (1:1): Group 1 will administer standard eyedrops everyday for three months before crossing over to administering Nanodropper-mediated microdrops daily for three months and Group 2 will administer Nanodropper-mediated microdrops everyday for three months before crossing over to administering standard eyedrops daily for three months. At the visit that precedes the onset of the standard eyedrops treatment period, subjects will receive education on how to properly instill eyedrops. At the visit that precedes the onset of the Nanodropper treatment period, patients will receive education on how to properly instill eyedrops with the Nanodropper as well as one Nanodropper per bottle of prescription eyedrops. Patients will be instructed to use the Nanodropper with their bottle of eyedrops until the bottle is nearly depleted and they are due for a refill. Because the Nanodropper isn't reusable, subjects will be instructed to contact the clinic for additional Nanodroppers at the time that they refill their prescriptions. At each clinic visit, the IOP of each eye will be measured at 8 AM, 10 AM, and 12 PM using a calibrated Goldmann applanation tonometer by a masked evaluator. Additionally, surveys designed to assess whether Nanodropper impacts the financial burden and side effect profiles associated with chronic eyedrop use, as well as the usability of Nanodropper compared to standard eyedrop bottles, will be administered.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Nanodropper adaptor, control
- Keywords
- glaucoma, ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanodropper adaptorDevice
Patients will use their standard prescription for open-angle glaucoma or ocular hypertension with a Nanodropper attachment on the medication bottle.
controlDevice
Patients will use their prescribed IOP-lowering medication using standard eyedropper on the medication bottle.
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Standard eyedrops of IOP-lowering medications Receives: Device: control |
| Nanodropper | Experimental | Microdrops of IOP-lowering medications using Nanodropper adaptor Receives: Device: Nanodropper adaptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP (mm Hg)
Mean IOP ± SEM following three months of treatment with each modality. The change in IOP from baseline and the percent change in IOP from baseline are supportive efficacy endpoints.
Measured: 6 months
Secondary outcomes (3)
Adverse events
Survey scores of treatment-related adverse events that patients experience under each treatment modality will be compared
Measured: 6 months
Premature bottle exhaustion
Survey scores of how frequently patients run out of their eyedrops before insurance will cover their next refill under each treatment modality will be compared
Measured: 6 months
Socioeconomic strain
Survey scores of socioeconomic strain and the financial burden associated with chronic eyedrop use under each treatment modality will be compared
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start28 Feb 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- crossover assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghu Mudumbai, University of Washington
- Investigators
- Raghu Mudumbai, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277870
- Sponsor's protocol ID
- STUDY00013248
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nanodropper vs. Standard Eyedropper in Patients With Glaucoma and Ocular Hypertension
- ClinicalTrials.gov ID
- NCT05277870
- Acronym / sponsor ID
- STUDY00013248
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- glaucoma, ocular hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient population.
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 medications (experimental intervention) compared to standard eyedrops of the same medications (active comparator) in open-angle glaucoma or ocular hypertension patients at Harborview Eye Institute, for which permission has been obtained. A pre-study visit will be held before the start of the trial in which participant clinical histories will be documented and an ocular examination will be performed. Patients will be enrolled in the study by satisfying all the inclusion and none of the exclusion criteria. This 6-month study will include three clinic visits: a baseline visit at t = 0, crossover visit at t = 3 months, and final visit at t = 6 months. At the baseline visit, patients will be randomly assigned to one of two treatment groups (1:1): Group 1 will administer standard eyedrops everyday for three months before crossing over to administering Nanodropper-mediated microdrops daily for three months and Group 2 will administer Nanodropper-mediated microdrops everyday for three months before crossing over to administering standard eyedrops daily for three months. At the visit that precedes the onset of the standard eyedrops treatment period, subjects will receive education on how to properly instill eyedrops. At the visit that precedes the onset of the Nanodropper treatment period, patients will receive education on how to properly instill eyedrops with the Nanodropper as well as one Nanodropper per bottle of prescription eyedrops. Patients will be instructed to use the Nanodropper with their bottle of eyedrops until the bottle is nearly depleted and they are due for a refill. Because the Nanodropper isn't reusable, subjects will be instructed to contact the clinic for additional Nanodroppers at the time that they refill their prescriptions. At each clinic visit, the IOP of each eye will be measured at 8 AM, 10 AM, and 12 PM using a calibrated Goldmann applanation tonometer by a masked evaluator. Additionally, surveys designed to assess whether Nanodropper impacts the financial burden and side effect profiles associated with chronic eyedrop use, as well as the usability of Nanodropper compared to standard eyedrop bottles, will be administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- crossover assignment
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Device: controlStandard eyedrops of IOP-lowering medications |
| Nanodropper | Experimental | Device: Nanodropper adaptorMicrodrops of IOP-lowering medications using Nanodropper adaptor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanodropper adaptorPatients will use their standard prescription for open-angle glaucoma or ocular hypertension with a Nanodropper attachment on the medication bottle. | Device | Nanodropper |
| controlPatients will use their prescribed IOP-lowering medication using standard eyedropper on the medication bottle. | Device | control |
Primary outcome
IOP (mm Hg)
Time frame: 6 months
Mean IOP ± SEM following three months of treatment with each modality. The change in IOP from baseline and the percent change in IOP from baseline are supportive efficacy endpoints.
3 secondary outcomes
Adverse events
Time frame: 6 months
Premature bottle exhaustion
Time frame: 6 months
Socioeconomic strain
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Nanodropper websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raghu Mudumbai principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanodropper adaptor in people with Glaucoma, Open-Angle and Ocular Hypertension, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simona Vuletic (206-520-9728, simona@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (mm Hg) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.