Trial Outcomes & Findings for Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center (NCT NCT02867995)
NCT ID: NCT02867995
Last Updated: 2019-02-15
Results Overview
Intraocular pressure (IOP) is measured by Goldman applanation in patients and is expressed in mmHg. The IOP, which is a routine check in the ophthalmic exam, was measured in the eye drop aid group prior to starting drop aid use and at six weeks while using drop aids. IOP was measured at baseline and at 6 weeks in the control group. A significant increase in IOP is defined as an increase of 4 mmHg or more, a significant decreases in IOP is defined as a decrease of 4mmHg or more. No significant change in the IOP is a change between 1-3 mmHg.
COMPLETED
NA
39 participants
baseline and 6 weeks
2019-02-15
Participant Flow
Participant milestones
| Measure |
Control
No glaucoma drop aid control
|
Eye Drop Aids
Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)
Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
30
|
|
Overall Study
COMPLETED
|
9
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Control
No glaucoma drop aid control
|
Eye Drop Aids
Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)
Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center
Baseline characteristics by cohort
| Measure |
No Drop Aid
n=9 Participants
No glaucoma drop aid received- control
|
Drop Aid
n=30 Participants
Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)
Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
30 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Glaucoma
|
9 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 weeksIntraocular pressure (IOP) is measured by Goldman applanation in patients and is expressed in mmHg. The IOP, which is a routine check in the ophthalmic exam, was measured in the eye drop aid group prior to starting drop aid use and at six weeks while using drop aids. IOP was measured at baseline and at 6 weeks in the control group. A significant increase in IOP is defined as an increase of 4 mmHg or more, a significant decreases in IOP is defined as a decrease of 4mmHg or more. No significant change in the IOP is a change between 1-3 mmHg.
Outcome measures
| Measure |
Eye Drop Aids
n=27 Participants
Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)
Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
|
Control
n=9 Participants
No glaucoma drop aid control
|
Simply Touch
Participants placed in this group were given the Simply Touch Eye Drop Applicator in order to instill their eye drops.
|
Control
No glaucoma drop aid control
|
|---|---|---|---|---|
|
Number of Participants Assessed for Intraocular Pressure Change
Significant increase in IOP
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Assessed for Intraocular Pressure Change
Significant decrease in IOP
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Assessed for Intraocular Pressure Change
No change in IOP
|
15 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Participants include those who were compliant with their drop aid device throughout the length of their medication bottle, as well as those who were non-compliant with their device group.
A question on the six week survey asked approximately how often the participant missed their eye when inserting eye drops. Response options included: missed inserting eye drops 0 times, missed inserting eye drops 1 time, missed inserting eye drops 2 times, or missed inserting eye drops 3 or more times.
Outcome measures
| Measure |
Eye Drop Aids
n=27 Participants
Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)
Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
|
Control
n=9 Participants
No glaucoma drop aid control
|
Simply Touch
Participants placed in this group were given the Simply Touch Eye Drop Applicator in order to instill their eye drops.
|
Control
No glaucoma drop aid control
|
|---|---|---|---|---|
|
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
Missed inserting eye drops 0 times
|
10 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
Missed inserting eye drops 1 times
|
8 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
Missed inserting eye drops 2 times
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
Missed inserting eye drops 3 or more times
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
No Data Available
|
6 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Participants include all enrolled patients who completed the study. The drop aid group was stratified into the three types of aids- AutoDrop, Autosqueeze, and Simply Touch.
A question on the six week survey asked if the participant liked the eye drop aid. Response options included: liked the drop aid long term, did not like the drop aid, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).
Outcome measures
| Measure |
Eye Drop Aids
n=8 Participants
Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)
Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
|
Control
n=7 Participants
No glaucoma drop aid control
|
Simply Touch
n=9 Participants
Participants placed in this group were given the Simply Touch Eye Drop Applicator in order to instill their eye drops.
|
Control
n=9 Participants
No glaucoma drop aid control
|
|---|---|---|---|---|
|
Satisfaction With Eye Drop Aid
Liked Drop Aid
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Satisfaction With Eye Drop Aid
Did Not Like Drop Aid
|
2 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Satisfaction With Eye Drop Aid
Did not use Drop Aid
|
0 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Participants include all enrolled patients who completed the study. The drop aid group was stratified into the three types of aids- AutoDrop, Autosqueeze, and Simply Touch.
A question on the six week survey asked if the participant intended to use the eye drop aid long term. Response options included: would use the drop aid long term, would not use the drop aid long term, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).
Outcome measures
| Measure |
Eye Drop Aids
n=8 Participants
Participants could be placed into one of the drop aid groups (Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator)
Eye Drop Aid: Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
|
Control
n=10 Participants
No glaucoma drop aid control
|
Simply Touch
n=9 Participants
Participants placed in this group were given the Simply Touch Eye Drop Applicator in order to instill their eye drops.
|
Control
n=9 Participants
No glaucoma drop aid control
|
|---|---|---|---|---|
|
Intent to Use Eye Drop Aid Long Term
Would use Drop Aid long term
|
6 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
|
Intent to Use Eye Drop Aid Long Term
Would not use Drop Aid long term
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Intent to Use Eye Drop Aid Long Term
Did not use Drop Aid
|
0 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
Adverse Events
Control
Eye Drop Aids
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