Health Trials

About this trial

To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%.

Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Eligibility criteria

Qualifiers

Adults ≥18 years of age.

Have a history of DED for at least the past 6 months.

Are currently using Xiidra as directed by their eye care provider for ≥1 month.

Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score [≥2 to <10 mm/5 min]) at Screening/Baseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.

Disqualifiers

Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).

Have a history of ocular surgery within the past 12 months.

Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.

Punctal plugs in place for < 3 months and/or Lacrifill in place for > 5 months.

Trial design

Treatments tested in this trial

  • acoltremon 0.003%

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Southern College of Optometry

Lead sponsor

Source ClinicalTrials.gov