Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon
United States50 participantsStarted 2025-11-24
Plain-language summary
To evaluate the impact of Acoltremon 0.003% on subjective dry eye symptoms using validated patient-reported outcome measures: Eye Dryness Score Visual Analog Scale (EDS-VAS). The primary aim is to characterize the rapidity of symptomatic relief in moderate to severe dry eye disease (DED), with attention to short-term therapy.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Adults aged 18 years or older with clinical diagnosis of DED within past 6 months
* Use or desire for artificial tears for DED symptoms within past 2 months
* OSDI score \>25 and \<50 at Screening
* TBUT \<10 seconds
* Baseline tCFS score ≥2 and ≤15 (modified NEI)
Exclusion Criteria:
* History of corneal or conjunctival surgery
* History of herpes zoster ophthalmicus, herpes simplex virus keratitis, or other viral corneal infection
* History of neurotrophic keratitis
* Prior significant facial trauma or sinus surgery
* Mental or physical condition impairing ability to complete questionnaires
* Use of Restasis®, Xiidra®, or Miebo within 30 days
* Use of other topical anti-inflammatory medications within 30 days
* Use of varenicline nasal spray within 30 days
* Use of artificial tears within 2 hours prior to screening or during study period
* Glaucoma requiring topical therapy
* Contact lens or eyelid scrub use within 7 days
* Punctal plugs within 14 days
* Oxervate historical use
* Amniotic membrane or Serum Tears historical use
* History of Sjögren's disease
* History of LASIK within 1 year
What they're measuring
1
Change from baseline in Ocular Surface Disease Index at 28 days