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Eye Drop Application Monitor, Pilot Study

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: NCT02639845
Recruitment Status : Unknown
Verified December 2015 by Alexander Eaton, Retina Health Center.
Recruitment status was:  Recruiting
First Posted : December 28, 2015
Last Update Posted : December 28, 2015
Sponsor:
Collaborators:
California Retina Consultants
Konowal Vision Center
Southwest Florida Eye Care
Information provided by (Responsible Party):
Alexander Eaton, Retina Health Center

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.

Condition or disease
Cataracts Retina Surgery Glaucoma Any Condition That Requires Ophthalmic Drops

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Eye Drop Application Monitor to Assess Patient Compliance With a Prescribed Regimen
Study Start Date : November 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Variation from a Prescribed Ophthalmic Drop Regimen [ Time Frame: Up to four weeks of monitoring beginning immediately after eye drops are prescribed ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who are scheduled to receive prescription eye drops, one of which must be applied at least once a day.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Children (patients < 18 years old)
  • Those unable to self-consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639845


Contacts
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Contact: Soratree Charoenthongtrakul, Ph.D. 239-337-3337 ext 245 soratree@retinahealthcenter.com
Contact: Alexander M Eaton, M.D. 239-337-3337 ext 208 Dr.Eaton@retinahealthcenter.com

Locations
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United States, Florida
Retina Health Center Recruiting
Fort Myers, Florida, United States, 33907
Contact: Soratree Charoenthongtrakul, Ph.D.    239-337-3337 ext 245    soratree@retinahealthcenter.com   
Contact: Alexander M Eaton, M.D.    239-337-3337 ext 208    dr.eaton@retinahealthcenter.com   
Sponsors and Collaborators
Alexander Eaton
California Retina Consultants
Konowal Vision Center
Southwest Florida Eye Care
Investigators
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Study Director: Soratree Charoenthongtrakul, Ph.D. Retina Health Center
Publications of Results:
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Responsible Party: Alexander Eaton, Managing Partner, Retina Health Center
ClinicalTrials.gov Identifier: NCT02639845    
Other Study ID Numbers: EDIT Phase I
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cataract
Eye Diseases
Lens Diseases