Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

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.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Colvard-Kandavel Eye Center

Encino, California, 91316, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acoltremon

Drug

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).

Primary outcomes

Change from baseline in Ocular Surface Disease Index at 28 days

Time frame: 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

Sponsors and collaborators

Lead sponsor

Colvard Kandavel Eye Center

Other

Registry information

Official study title

Acoltremon Symptom Tracking and Relief Assessment in Moderate-to-Severe Dry Eye Disease

Acronym: ASTRA

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Dec 8, 2025
Registry last updated: Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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