Eye Drop Application Monitor, Pilot Study
A Novel Eye Drop Application Monitor to Assess Patient Compliance With a Prescribed Regimen
1 other identifier
observational
500
1 country
1
Brief Summary
The purpose of this study is to determine if an eye drop video monitoring device can accurately assess (as compared to a patient's own log or a proprietary software) the exact amount and time of eye drop delivery to a patient's eye. It is our belief that the experimental device will help patients to be more compliant by: 1) providing a viewable format so patients can see what is happening when they are applying their drops 2) providing greater accuracy to doctors regarding when and how much medication was used 3) providing greater accuracy to doctors and patients regarding how much medication was actually delivered to a patients eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 28, 2015
December 1, 2015
3.1 years
December 18, 2015
December 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Variation from a Prescribed Ophthalmic Drop Regimen
The Eye Drop Application Monitor will be brought to the reading center based at Retina Health Center (Fort Myers, FL) at the end of each use. A trained technician will then document the time of drop delivery and how many drops got in the eye.
Up to four weeks of monitoring beginning immediately after eye drops are prescribed
Study Arms (1)
Patients Prescribed Eye Drops
Patients who are scheduled to receive prescription eye drops due to complications such as cataract surgery, glaucoma, retina surgery, or eye-related condition.
Eligibility Criteria
Patients who are scheduled to receive prescription eye drops, one of which must be applied at least once a day.
You may qualify if:
- Patients who are scheduled to receive prescription eye drops
- Eye drop(s) must be applied at least once a day.
- Caregivers who apply drops for patients
You may not qualify if:
- Children (patients \< 18 years old)
- Those unable to self-consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexander Eatonlead
- California Retina Consultantscollaborator
- Konowal Vision Centercollaborator
- Southwest Florida Eye Carecollaborator
Study Sites (1)
Retina Health Center
Fort Myers, Florida, 33907, United States
Related Publications (1)
Eaton AM, Gordon GM, Konowal A, Allen A, Allen M, Sgarlata A, Gao G, Wafapoor H, Avery RL. A novel eye drop application monitor to assess patient compliance with a prescribed regimen: a pilot study. Eye (Lond). 2015 Oct;29(10):1383-91. doi: 10.1038/eye.2015.155. Epub 2015 Sep 11.
PMID: 26358235RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Soratree Charoenthongtrakul, Ph.D.
Retina Health Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Managing Partner
Study Record Dates
First Submitted
December 18, 2015
First Posted
December 28, 2015
Study Start
November 1, 2013
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
December 28, 2015
Record last verified: 2015-12