Colvard Kandavel Eye Center
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.
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…
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).
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