Dry Eye Disease (DED)
Conditions
Keywords
Dry Eye, Dry Eye Disease, Acoltremon
Brief 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.
Interventions
DRUGAcoltremon
Patients will administer Acoltremon 0.003% as per labeled directions. Assessments with the Ocular Surface Disease Index (OSDI) will occur at Baseline, treatment at 14 days, and treatment at 28 days. Secondary endpoints include change from baseline rating scale 1-5 in severity of various symptoms of dry eye: Blurriness, eye irritation/Discomfort, Burning/Stinging, Photophobia/Pain, Sandy/gritty/Foreign Body Sensation, Fatigue/Tired Eyes).
Sponsors
Colvard Kandavel Eye Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Ocular Surface Disease Index at 28 days | Baseline and 28 days | Change from baseline in specific 1-5 categorical rating scale scoring at 28 days of dry eye symptoms: Blurriness, burning/stinging, eye irritation/discomfort, photophobia/pain, tired eyes/eye fatigue, sandy/gritty/foreign body sensation |
Countries
United States
Outcome results
None listed