Ocular InjuryNCT05307081
An Observational, Qualitative Study Assessing Eye Drop Administration
An observational study of Ocular Injury, run by Ocular Therapeutix, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ocular Injury
- What is being tested?
- Artificial Tears
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Patients or parents of minor patients who consent to participating in the study
Who cannot join
- Any patient who does not consent to study participation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Alyssa Paolini
About this study
Official title: 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.
Read the 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.
- Conditions
- Ocular Injury
- Being tested
- Artificial Tears
- Medical subject headings
- Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial TearsDrug
Artificial Tears are an FDA approved intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: 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
Measured: 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
Measured: three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start21 Apr 2022
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ocular InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307081
- Sponsor's protocol ID
- TEAR-2020-401
- Status last verified
- Sep 2022
- First submitted
- 22 Oct 2020
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25248295Hennessy 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.
PubMed 21821228
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Consecutive, Qualitative, Multicenter Study Assessing Eye Drop Administration
- ClinicalTrials.gov ID
- NCT05307081
- Acronym / sponsor ID
- TEAR-2020-401
- Conditions
- Ocular Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Artificial Tears |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients or parents of minor patients who consent to participating in the study
Key exclusion criteria (1 listed)
- Any patient who does not consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial TearsArtificial Tears are an FDA approved intervention | Drug | 1 |
Primary outcome
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
Time frame: There will be a total of three eye drop administration attempts - Two attempts occur on the first visit (Day 0)
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)
3 secondary outcomes
Proportion of patients who meet each individual failure criterion on first, second, and third attempt session
Time frame: 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
Time frame: 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.
Time frame: three eye drop administration attempts - Two attempts on the first visit (Day 0) and one attempt at second visit (Day 30 +/- 7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Results publicationCataract 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
- Results publication: PubMed 25248295An 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.
- Results publication: PubMed 21821228Hennessy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Injury, run by Ocular Therapeutix, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Paolini, BS (781-457-2992, apaolini@ocutx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: There will be a total of three eye drop administration attempts - Two attempts occur on the first visit (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.