Switching From Xiidra to TRYPTYR
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorSouthern College of Optometry
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 groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov