Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04125134
Eligibility Criteria:
Inclusion Criteria:
Group 1 (Hypertonic saline non-responders):
* At least 18 years of age
* Ability to consent
* Diagnosis of Dry Eye Disease (DED) based on:
* Symptoms of DED, shown with SANDE score of 50mm or greater
* Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands
* HS response result of one of the following:
* Reduction of discomfort/pain rating
* No change of discomfort/pain rating
* Increase in discomfort/pain rating score of 1 step or less
Group 2 (Hypertonic saline non-responders):
* At least 18 years of age
* Ability to consent
* Diagnosis of DED based on:
* Symptoms of DED, shown with SANDE score 50mm or greater
* Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands
* HS response result of an increase in discomfort/pain rating of greater than 1 step
Exclusion Criteria:
* Presence of centralized pain as indicated by a proparacaine challenge test (PCT) of less than 50% ocular surface discomfort reduction
* Unable to speak English
* History of ocular surgery, corneal infection, or corneal injury within the last 3 months
* Active ocular allergies or other condition that could impact the study results
* Allergic to benzalkonium chloride "BAK" (an eye-drop preservative)
* Changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment
* Use of other topical treatments
* Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study
* Use of contact lenses within the last month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04125134
Study Brief:
Protocol Section:
NCT04125134