An Observational, Qualitative Study Assessing Eye Drop Administration

A Prospective, Observational, Consecutive, Qualitative, Multicenter Study Assessing Eye Drop Administration

This is a prospective, observational, consecutive, qualitative, multicenter study. Based on the available published evidence that supports patient challenges with eyedrop administration, the purpose of this video-capture study is to evaluate a more real-world population of consenting patients, regardless of age, with or without visual impairment, at routine eyecare visits.

To date, no studies have been performed evaluating a real-world population consisting of daily routine eyecare clinic patients with or without visual impairment. This study will help to determine the ability to achieve success with self-administration of eyedrops in the real world.

Study Overview

• Status: Recruiting
• Conditions: Ocular Injury
• Intervention / Treatment: Drug: Artificial Tears

Detailed Description

Introduction: This is a prospective, observational, consecutive, qualitative, multicenter study. A robust body of evidence suggests patients demonstrate challenges with eyedrop adherence and improper administration. The current standard of care following ophthalmic surgery is topical treatment with corticosteroids, antibiotics, and NSAIDs. Prospectively evaluated patients accuracy in administering eyedrops, during the post-operative period of cataract surgery, with 92.6% of patients demonstrating at least one type of improper administration technique. Few examples of possible errors included neglect of handwashing, failure to shake the eyedrop bottle, contamination of the bottle tip, incorrect amount of drops, and even missing the ocular surface entirely. Additionally, there was an incongruence between patient's impression of their technique and physician's observation. Thirty-five percent of patients who reported not missing the eye, did miss the eye under observation, and 39.3% of the patients who believed they never touched the eye with the bottle tip, did touch the ocular surface.

Similar studies were also performed in visually impaired patients due to glaucoma and retinal diseases with up to 47% of patients with retinal diseases touching the bottle to the eye, and up to 30% of patients not being able to administer a drop into the eye.

The objective of this study is to assess the accuracy of successful eye drop administration in patients undergoing routine exams.

This study also seeks to understand the discrepancy between patient impressions of eyedrop instillation success compared to success determined by ophthalmologist and optometrist evaluation.

Study Design This study will video capture adult subjects or Legal Authorized Representative (LAR) for minor subject's administration of one artificial tear onto the ocular surface. A temporal view video recording will be obtained. Subjects age 11 or older will self-administer the eye drops. Subjects age 10 or younger will have eye drops administer by the subject's LAR. Adult subjects or LAR will administer the drop with their dominant hand in the eye of the subject's preference.

Subjects age 11 or older shall be in a seated position while the eye drops are self-administered. Subjects age 10 or younger can either be seated or laid based on the LAR's preference.

There will be a total of three eye drop administration attempts - two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days). The first eye drop administration attempt will be without coaching. The subject will then receive eye drop administration technique improvement coaching by study staff and a second eye drop administration with video recording will be obtained. One month later, the subject will return at visit 2 for a third attempt for eye drop administration without any additional coaching (to observe the retention of previous eye-drop administration technique coaching) and a video recording will be obtained.

All video recordings will then be retrospectively evaluated by independent ophthalmologist and optometrist graders according to pre-specified success and failure criteria.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Alyssa Paolini, BS; Phone Number: 781-457-2992; Email: apaolini@ocutx.com

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Vance Thompson Vision
      • Contact: Alyssa Paolini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consented, routine, and real world eyecare clinic patient population, regardless of age, with or without visual impairment, willing to administer an artificial tear with video capture.

Description

Inclusion Criteria:

• Patients or parents of minor patients who consent to participating in the study

Exclusion Criteria:

• Any patient who does not consent to study participation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1	Drug: Artificial Tears; Artificial Tears are an FDA approved intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who meet pre-specified "success" criteria for proper administration of eye drop onto ocular surface on first attempt session as evaluated by the ophthalmologist or optometrist grader	Eye drop administration success = one drop accurately falling onto the ocular surface with single drop administration without the tip of the eye drop bottle touching the hands or eye (including the eyelid, conjunctiva, eyelashes)	There will be a total of three eye drop administration attempts - Two attempts occur on the first visit (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who meet each individual failure criterion on first, second, and third attempt session	Eye drop administration failure =; Two or more eye drops administered onto the eye; Eye drop missing the eye; Touching the tip of the eye drop bottle to the eyelid, conjunctiva, eyelashes, or hands	three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days).
Proportion of patient eye drop administration "success" as evaluated by patient self-assessment on first, second, and third attempt sessions	Patient self-evaluation success = a rating of 6 or higher on Likert scale	three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days).
Agreement between optometrist and ophthalmologist graders and patient eye drop administration "success" outcomes on first, second and third attempt sessions as measured by calculated Kappa statistic.	Physician evaluated eye drop administration success = one drop accurately falling onto the ocular surface on the first attempt • Patient self-evaluation success = a rating of 6 or higher on Likert scale	three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days)

Collaborators and Investigators

• Sponsor: Ocular Therapeutix, Inc.

Publications and helpful links

General Publications

• Cataract Surgeons for Improved Eyecare(CSIE). Analysis of the economic impacts of dropless cataract therapy on Medicare, Medicaid, state governments, and patient costs. October 2015. http://stateofreform.com/wp-content/uploads/2015/11/CSIE_Dropless_Economic_Study.pdf
• An JA, Kasner O, Samek DA, Levesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61. doi: 10.1016/j.jcrs.2014.02.037. Epub 2014 Sep 22.
• Hennessy AL, Katz J, Covert D, Kelly CA, Suan EP, Speicher MA, Sund NJ, Robin AL. A video study of drop instillation in both glaucoma and retina patients with visual impairment. Am J Ophthalmol. 2011 Dec;152(6):982-8. doi: 10.1016/j.ajo.2011.05.015. Epub 2011 Aug 6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (ACTUAL): April 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Eye Injuries; Pharmaceutical Solutions; Ophthalmic Solutions; Lubricant Eye Drops
• Other Study ID Numbers: TEAR-2020-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No