Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon (ASTRA)

Colvard Kandavel Eye Center

Status: Invitation-only

Conditions: Dry Eye Disease (DED)

Treatments: Drug: Acoltremon

Study type: Observational

Funder types: Other

Identifiers

NCT07268599

ASTRA-25859

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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