Eye tests may predict dry eye relief from artificial tears
NCT ID NCT04125134
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study aimed to see if certain eye tests could predict which people with dry eye disease would get relief from over-the-counter artificial tears. Researchers planned to enroll 66 adults with dry eye, but the study was terminated early with only 36 participants. Participants used preservative-free lubricant eye drops twice daily for 4 weeks and completed symptom questionnaires and eye exams.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Preservative-free artificial tears (lubricant eye drops)
- What this could lead to
- If successful, this could help doctors predict which dry eye patients will respond best to artificial tears, leading to more personalized treatment.
- What could go wrong
- The study was terminated early with only 36 participants, so results are limited and may not be reliable. It is a small, single-site trial with no clear outcome yet.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
36 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Jul 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Tufts Medical Center-New England Eye Center
Boston, Massachusetts, 02111, United States
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