Switching From Xiidra to TRYPTYR (NCT07267481) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Switching From Xiidra to TRYPTYR
100 participantsStarted 2025-12-15
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Have corrected distance visual acuity of 20/40 or better.
* Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.
Exclusion Criteria:
* 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.
* Have ever used Accutane
* Currently using ocular medications, including topical anti-inflammatory drops, (other than Xiidra) 1 month prior to enrollment
* Any artificial tear use at enrollment must remain consistent throughout the study.
* Are pregnant or breast feeding.
* Have had a physical meibomian gland treatment withing 1 month of enrollment.
* Initiated, discontinued or changed dose of a systemic medication known to cause ocular drying (e.g., antihistam…
What they're measuring
1
Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1