Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Glaucoma Drop Aids in Medication Compliance in the Patient Population at Boston Medical Center

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02867995
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Manishi Desai, Boston Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Glaucoma
Intervention Device: Eye Drop Aid
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Eye Drop Aids
Hide Arm/Group Description No glaucoma drop aid control

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

Period Title: Overall Study
Started 9 [1] 30 [1]
Completed 9 [2] 27 [2]
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             0             2
[1]
Total patients consented
[2]
Total patients completed
Arm/Group Title No Drop Aid Drop Aid Total
Hide Arm/Group Description No glaucoma drop aid received- control

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 of all reporting groups
Overall Number of Baseline Participants 9 30 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  22.2%
17
  56.7%
19
  48.7%
>=65 years
7
  77.8%
13
  43.3%
20
  51.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 39 participants
Female
2
  22.2%
16
  53.3%
18
  46.2%
Male
7
  77.8%
14
  46.7%
21
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 39 participants
Hispanic or Latino
0
   0.0%
1
   3.3%
1
   2.6%
Not Hispanic or Latino
9
 100.0%
29
  96.7%
38
  97.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  11.1%
0
   0.0%
1
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  55.6%
21
  70.0%
26
  66.7%
White
1
  11.1%
5
  16.7%
6
  15.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  22.2%
4
  13.3%
6
  15.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 30 participants 39 participants
9 30 39
Glaucoma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 39 participants
9
 100.0%
30
 100.0%
39
 100.0%
1.Primary Outcome
Title Number of Participants Assessed for Intraocular Pressure Change
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Eye Drop Aids
Hide Arm/Group Description:
No glaucoma drop aid control

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 Number of Participants Analyzed 9 27
Measure Type: Count of Participants
Unit of Measure: Participants
Significant increase in IOP
0
   0.0%
4
  14.8%
Significant decrease in IOP
4
  44.4%
8
  29.6%
No change in IOP
5
  55.6%
15
  55.6%
2.Secondary Outcome
Title Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control Eye Drop Aids
Hide Arm/Group Description:
No glaucoma drop aid control

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 Number of Participants Analyzed 9 27
Measure Type: Count of Participants
Unit of Measure: Participants
Missed inserting eye drops 0 times
3
  33.3%
10
  37.0%
Missed inserting eye drops 1 times
5
  55.6%
8
  29.6%
Missed inserting eye drops 2 times
0
   0.0%
1
   3.7%
Missed inserting eye drops 3 or more times
1
  11.1%
2
   7.4%
No Data Available
0
   0.0%
6
  22.2%
3.Secondary Outcome
Title Satisfaction With Eye Drop Aid
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title AutoDrop Autosqueeze Simply Touch Control
Hide Arm/Group Description:
Patients placed in this group were given the Fabrication Autodrop Eye Drop Guide to instill their eye drops with
Participants placed in this group were given the Owen Mumford OP 6100 Autosqueeze in order to instill their eye drops.
Participants placed in this group were given the Simply Touch Eye Drop Applicator in order to instill their eye drops.
No glaucoma drop aid control
Overall Number of Participants Analyzed 7 8 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Liked Drop Aid
3
  42.9%
6
  75.0%
3
  33.3%
0
   0.0%
Did Not Like Drop Aid
4
  57.1%
2
  25.0%
4
  44.4%
0
   0.0%
Did not use Drop Aid
0
   0.0%
0
   0.0%
2
  22.2%
9
 100.0%
4.Secondary Outcome
Title Intent to Use Eye Drop Aid Long Term
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title AutoDrop Autosqueeze Simply Touch Control
Hide Arm/Group Description:
Patients placed in this group were given the Fabrication Autodrop Eye Drop Guide to instill their eye drops with
Participants placed in this group were given the Owen Mumford OP 6100 Autosqueeze in order to instill their eye drops.
Participants placed in this group were given the Simply Touch Eye Drop Applicator in order to instill their eye drops.
No glaucoma drop aid control
Overall Number of Participants Analyzed 10 8 9 9
Measure Type: Count of Participants
Unit of Measure: Participants
Would use Drop Aid long term
9
  90.0%
6
  75.0%
3
  33.3%
0
   0.0%
Would not use Drop Aid long term
1
  10.0%
2
  25.0%
4
  44.4%
0
   0.0%
Did not use Drop Aid
0
   0.0%
0
   0.0%
2
  22.2%
9
 100.0%
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Eye Drop Aids
Hide Arm/Group Description No glaucoma drop aid received- control

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

All-Cause Mortality
Control Eye Drop Aids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Eye Drop Aids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Eye Drop Aids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Manishi Desai
Organization: Boston Medical Center
Phone: 671-414-8806
Responsible Party: Manishi Desai, Boston Medical Center
ClinicalTrials.gov Identifier: NCT02867995     History of Changes
Other Study ID Numbers: H-34905
First Submitted: August 7, 2016
First Posted: August 16, 2016
Results First Submitted: December 11, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019