Trial Outcomes & Findings for Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma (NCT NCT05273385)
NCT ID: NCT05273385
Last Updated: 2026-03-05
Results Overview
IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
At Baseline
Results posted on
2026-03-05
Participant Flow
Baseline visit was done after a wash out period of 4-5 weeks was completed.
Participant milestones
| Measure |
Standard of Care
This group administered the IOP lowering eye drops as standard of care.
|
Nanodropper
This group administered the IOP lowering eye drops using the Nanodropper.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma
Baseline characteristics by cohort
| Measure |
Standard of Care
n=7 Participants
This group administered the IOP lowering eye drops as standard of care.
|
Nanodropper
n=6 Participants
This group administered the IOP lowering eye drops using the Nanodropper.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.3 number of years
STANDARD_DEVIATION 11.1 • n=41 Participants
|
66.5 number of years
STANDARD_DEVIATION 8.7 • n=35 Participants
|
70.2 number of years
STANDARD_DEVIATION 10.3 • n=76 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
5 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
8 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
|
Participants with both Goldmann Applanation and Pneumotonometer IOP Measured
|
7 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
13 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: At BaselinePopulation: Only patients with completed data was analyzed.
IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Outcome measures
| Measure |
Nanodropper
n=6 Participants
Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
|
Standard of Care Dropper
n=7 Participants
Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.
|
Standard of Care Right Eye
Participants right eye who were randomized to the standard of care arm.
|
Standard of Care Left Eye
Participants left eye who were randomized to the standard of care arm.
|
|---|---|---|---|---|
|
Intraocular Pressure (IOP) at Baseline
Goldmann Right Eye
|
21.1 mmHg
Standard Deviation 4.0
|
18.4 mmHg
Standard Deviation 4.5
|
—
|
—
|
|
Intraocular Pressure (IOP) at Baseline
Goldmann Left Eye
|
20.1 mmHg
Standard Deviation 3.6
|
19.3 mmHg
Standard Deviation 5.9
|
—
|
—
|
|
Intraocular Pressure (IOP) at Baseline
Pneumotonometer Right Eye
|
21.3 mmHg
Standard Deviation 4.1
|
20.1 mmHg
Standard Deviation 7.2
|
—
|
—
|
|
Intraocular Pressure (IOP) at Baseline
Pneumotonometer Left Eye
|
22.6 mmHg
Standard Deviation 4.3
|
20.6 mmHg
Standard Deviation 6.9
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Only patients with completed data was analyzed.
IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Outcome measures
| Measure |
Nanodropper
n=6 Participants
Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
|
Standard of Care Dropper
n=7 Participants
Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.
|
Standard of Care Right Eye
Participants right eye who were randomized to the standard of care arm.
|
Standard of Care Left Eye
Participants left eye who were randomized to the standard of care arm.
|
|---|---|---|---|---|
|
Intraocular Pressure (IOP) at Month 1
Goldmann Left Eye
|
16.9 mmHg
Standard Deviation 2.8
|
16.8 mmHg
Standard Deviation 4.3
|
—
|
—
|
|
Intraocular Pressure (IOP) at Month 1
Pneumotonometer Right Eye
|
17.5 mmHg
Standard Deviation 3.3
|
18.9 mmHg
Standard Deviation 4.2
|
—
|
—
|
|
Intraocular Pressure (IOP) at Month 1
Pneumotonometer Left Eye
|
18.1 mmHg
Standard Deviation 3.0
|
19.2 mmHg
Standard Deviation 3.8
|
—
|
—
|
|
Intraocular Pressure (IOP) at Month 1
Goldmann Right Eye
|
17.4 mmHg
Standard Deviation 3.7
|
16.5 mmHg
Standard Deviation 4.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Only data from participants who completed all visits were analyzed.
IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Outcome measures
| Measure |
Nanodropper
n=6 Participants
Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
|
Standard of Care Dropper
n=7 Participants
Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.
|
Standard of Care Right Eye
Participants right eye who were randomized to the standard of care arm.
|
Standard of Care Left Eye
Participants left eye who were randomized to the standard of care arm.
|
|---|---|---|---|---|
|
Intraocular Pressure (IOP) at Month 3
Goldmann Right Eye
|
16.7 mmHg
Standard Deviation 3.3
|
14.6 mmHg
Standard Deviation 4.3
|
—
|
—
|
|
Intraocular Pressure (IOP) at Month 3
Goldmann Left Eye
|
16.3 mmHg
Standard Deviation 2.9
|
14.6 mmHg
Standard Deviation 4.3
|
—
|
—
|
|
Intraocular Pressure (IOP) at Month 3
Pneumotonometer Right Eye
|
17.2 mmHg
Standard Deviation 1.4
|
17.6 mmHg
Standard Deviation 4.2
|
—
|
—
|
|
Intraocular Pressure (IOP) at Month 3
Pneumotonometer Left Eye
|
17.6 mmHg
Standard Deviation 2.2
|
17.3 mmHg
Standard Deviation 3.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only the participants randomized to the nanodropper arm was surveyed.
The following open-ended questions will be administered to participants randomized to the Nanodropper group at the end of the 3-month study. 1. Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no) 2. Did you find the Nanodropper easy to use? (yes/no) 3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no)
Outcome measures
| Measure |
Nanodropper
n=6 Participants
Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
|
Standard of Care Dropper
Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.
|
Standard of Care Right Eye
Participants right eye who were randomized to the standard of care arm.
|
Standard of Care Left Eye
Participants left eye who were randomized to the standard of care arm.
|
|---|---|---|---|---|
|
Survey
1. Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no) · Yes
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Survey
1. Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no) · No
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Survey
1. Would you consider using the Nanodropper for your regular eye drop use in the future? (yes/no) · Missing
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Survey
2. Did you find the Nanodropper easy to use? (yes/no) · Yes
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Survey
2. Did you find the Nanodropper easy to use? (yes/no) · No
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Survey
2. Did you find the Nanodropper easy to use? (yes/no) · Missing
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Survey
3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no) · Yes
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Survey
3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no) · No
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Survey
3. Did using the Nanodropper cause more irritation compared to normal eye drop bottles? (yes/no) · Missing
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At baselinePopulation: We used the number of eyes not participants for this analysis.
Conjunctival grading will be performed by a masked ophthalmologist at the baseline study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome.
Outcome measures
| Measure |
Nanodropper
n=6 Eyes
Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
|
Standard of Care Dropper
n=4 Eyes
Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.
|
Standard of Care Right Eye
n=6 Eyes
Participants right eye who were randomized to the standard of care arm.
|
Standard of Care Left Eye
n=5 Eyes
Participants left eye who were randomized to the standard of care arm.
|
|---|---|---|---|---|
|
Conjunctival Grading at Baseline
|
28.3 scores on a scale
Standard Deviation 9.8
|
25.0 scores on a scale
Standard Deviation 10.0
|
32.9 scores on a scale
Standard Deviation 11.1
|
33.3 scores on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: We used the number of eyes not participants for this analysis.
Conjunctival grading will be performed by a masked ophthalmologist the 3 month study visit. Grading will be performed with redness graded on a scale of 0-100 using the bulbar redness grading 5-picture validated scale. A grade of 0 is considered to be the least red and therefore a better outcome. A grade of 100 is considered the most red and therefore a worse outcome.
Outcome measures
| Measure |
Nanodropper
n=6 eyes
Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
|
Standard of Care Dropper
n=4 eyes
Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.
|
Standard of Care Right Eye
n=6 eyes
Participants right eye who were randomized to the standard of care arm.
|
Standard of Care Left Eye
n=5 eyes
Participants left eye who were randomized to the standard of care arm.
|
|---|---|---|---|---|
|
Conjunctival Grading at Month 3
|
34.0 scores on a scale
Standard Deviation 13.4
|
32.5 scores on a scale
Standard Deviation 15.0
|
30.0 scores on a scale
Standard Deviation 10.0
|
33.3 scores on a scale
Standard Deviation 15.1
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nanodropper
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place