An Observational, Qualitative Study Assessing Eye Drop Administration

NCT05307081 | Unknown FDA Drug

• 1 other identifier: TEAR-2020-401
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of patients who meet each individual failure criterion on first, second, and third attempt session

  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

  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.

  three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days)

Study Arms (1)

1

Drug: Artificial Tears

Interventions

Artificial Tears DRUG

Artificial Tears are an FDA approved intervention

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Any patient who does not consent to study participation

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Related Publications (3)

• 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

  RESULT

• 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.

  PMID: 25248295 RESULT

• 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.

  PMID: 21821228 RESULT

MeSH Terms

Conditions

Eye Injuries

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Central Study Contacts

Alyssa Paolini, BS

CONTACT

781-457-2992; apaolini@ocutx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: April 1, 2022
• Study Start: April 21, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

US (1)