Glaucoma
Conditions
Keywords
glaucoma drop aid
Brief summary
The purpose of this study is to determine whether glaucoma drop aids will be cost-effective in delivery of ophthalmic medications by improving medication compliance, visual function, and even decreasing medication waste in the patient population at Boston Medical Center (BMC).
Detailed description
Patients being treated for their glaucoma at BMC's Yawkey Eye Clinic will be selected according to the inclusion and exclusion criteria. The three drop aids used in this study will be the Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator. Patients will be randomly placed on one of these drops aids for a total of 3 study groups or the no drop aid control, for a total of 4 groups. Prior to use of the drop aid, patients will be instructed on how to use the drop aid by a resident physician and a pre- intervention intraocular pressure check will be performed by the resident physician using an applicator. Intraocular pressure is the only adjustable risk factor for glaucoma; thus, glaucoma treatments slow progression of glaucoma by reducing intraocular pressure. In addition, patients will be requested to deliver their drops with the drop aid with every use. Furthermore, each patient will record the number of days taken to complete the glaucoma medication bottle while using the drop aid. At the 3 and 6 week marks, the patient will fill out a satisfaction survey. Patients will need to return to the clinic at the 6 week mark and can fill out the satisfaction survey at the clinic in addition to checking the intraocular pressure post-intervention. Thus, the number of subject contact will be two, pre and post-intervention, the duration of participation for each subject will be 6 weeks, and the patient will also be required to fill out two satisfaction surveys. The effectiveness of the drop aids will be compared to the two controls and measured with any changes in intraocular pressure readings, length of time to medication completion, and patient satisfaction according to the surveys.
Interventions
DEVICEEye Drop Aid
Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* age 18 years or greater * Currently on the same topical medication for treatment of glaucoma for a minimum of two months * Patient of Boston University eye Associates * Agrees to use the drop aid with each delivery, return to the clinic after 6 weeks of using the drop aid, document completion of medication drops and fill out survey at the end of the 6 weeks
Exclusion criteria
* Less than age 18 years * Changes glaucoma medication within the past two month or recent glaucoma surgery * Older than 89 years of age * Not a patient of the Boston University eye associate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Assessed for Intraocular Pressure Change | baseline and 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | 6 weeks | 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. |
| Satisfaction With Eye Drop Aid | 6 weeks | 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). |
| Intent to Use Eye Drop Aid Long Term | 6 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Drop Aid No glaucoma drop aid received- control | 9 |
| Drop Aid 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 | 30 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | No Drop Aid | Total | Drop Aid |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 20 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 19 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 38 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Glaucoma | 9 Participants | 39 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 26 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 1 Participants | 6 Participants | 5 Participants |
| Region of Enrollment United States | 9 participants | 39 participants | 30 participants |
| Sex: Female, Male Female | 2 Participants | 18 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 21 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 30 |
| other Total, other adverse events | 0 / 9 | 0 / 30 |
| serious Total, serious adverse events | 0 / 9 | 0 / 30 |
Outcome results
Primary
Number of Participants Assessed for Intraocular Pressure Change
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.
Time frame: baseline and 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants Assessed for Intraocular Pressure Change | Significant increase in IOP | 0 Participants |
| Control | Number of Participants Assessed for Intraocular Pressure Change | Significant decrease in IOP | 4 Participants |
| Control | Number of Participants Assessed for Intraocular Pressure Change | No change in IOP | 5 Participants |
| Eye Drop Aids | Number of Participants Assessed for Intraocular Pressure Change | Significant increase in IOP | 4 Participants |
| Eye Drop Aids | Number of Participants Assessed for Intraocular Pressure Change | Significant decrease in IOP | 8 Participants |
| Eye Drop Aids | Number of Participants Assessed for Intraocular Pressure Change | No change in IOP | 15 Participants |
Secondary
Intent to Use Eye Drop Aid Long Term
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).
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Intent to Use Eye Drop Aid Long Term | Would use Drop Aid long term | 9 Participants |
| Control | Intent to Use Eye Drop Aid Long Term | Would not use Drop Aid long term | 1 Participants |
| Control | Intent to Use Eye Drop Aid Long Term | Did not use Drop Aid | 0 Participants |
| Eye Drop Aids | Intent to Use Eye Drop Aid Long Term | Did not use Drop Aid | 0 Participants |
| Eye Drop Aids | Intent to Use Eye Drop Aid Long Term | Would use Drop Aid long term | 6 Participants |
| Eye Drop Aids | Intent to Use Eye Drop Aid Long Term | Would not use Drop Aid long term | 2 Participants |
| Simply Touch | Intent to Use Eye Drop Aid Long Term | Would not use Drop Aid long term | 4 Participants |
| Simply Touch | Intent to Use Eye Drop Aid Long Term | Would use Drop Aid long term | 3 Participants |
| Simply Touch | Intent to Use Eye Drop Aid Long Term | Did not use Drop Aid | 2 Participants |
| Control | Intent to Use Eye Drop Aid Long Term | Did not use Drop Aid | 9 Participants |
| Control | Intent to Use Eye Drop Aid Long Term | Would use Drop Aid long term | 0 Participants |
| Control | Intent to Use Eye Drop Aid Long Term | Would not use Drop Aid long term | 0 Participants |
Secondary
Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | Missed inserting eye drops 1 times | 5 Participants |
| Control | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | Missed inserting eye drops 3 or more times | 1 Participants |
| Control | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | Missed inserting eye drops 2 times | 0 Participants |
| Control | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | No Data Available | 0 Participants |
| Control | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | Missed inserting eye drops 0 times | 3 Participants |
| Eye Drop Aids | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | No Data Available | 6 Participants |
| Eye Drop Aids | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | Missed inserting eye drops 0 times | 10 Participants |
| Eye Drop Aids | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | Missed inserting eye drops 1 times | 8 Participants |
| Eye Drop Aids | Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops | Missed inserting eye drops 2 times | 1 Participants |
| Eye Drop Aids | 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 |
Secondary
Satisfaction With Eye Drop Aid
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).
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Satisfaction With Eye Drop Aid | Liked Drop Aid | 3 Participants |
| Control | Satisfaction With Eye Drop Aid | Did not use Drop Aid | 0 Participants |
| Control | Satisfaction With Eye Drop Aid | Did Not Like Drop Aid | 4 Participants |
| Eye Drop Aids | Satisfaction With Eye Drop Aid | Liked Drop Aid | 6 Participants |
| Eye Drop Aids | Satisfaction With Eye Drop Aid | Did not use Drop Aid | 0 Participants |
| Eye Drop Aids | Satisfaction With Eye Drop Aid | Did Not Like Drop Aid | 2 Participants |
| Simply Touch | Satisfaction With Eye Drop Aid | Did Not Like Drop Aid | 4 Participants |
| Simply Touch | Satisfaction With Eye Drop Aid | Liked Drop Aid | 3 Participants |
| Simply Touch | Satisfaction With Eye Drop Aid | Did not use Drop Aid | 2 Participants |
| Control | Satisfaction With Eye Drop Aid | Liked Drop Aid | 0 Participants |
| Control | Satisfaction With Eye Drop Aid | Did not use Drop Aid | 9 Participants |
| Control | Satisfaction With Eye Drop Aid | Did Not Like Drop Aid | 0 Participants |