Recruiting

Observational Study

Sponsor:

Ocular Therapeutix, Inc.

Code:

NCT05307081

Conditions

Ocular Injury

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Artificial Tears

Study Details

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

Study ID

NCT05307081

Start date

Apr 21, 2022

Status verified date

Sep, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Interventions

Artificial Tears

Artificial Tears are an FDA approved intervention

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) ]

Central Contacts and Locations

Central contacts

Locations

Vance Thompson Vision

Recruiting

Sioux Falls, South Dakota, United States, 57108

More Information

Sponsor

Ocular Therapeutix, Inc.

Last update posted

Sep 16, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ocular Therapeutix, Inc. on 2022-09-16.