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

December 4, 2025 updated by: Ganesha Kandavel, Colvard Kandavel Eye Center

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Colvard-Kandavel Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Colvard-Kandavel Eye Center patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colvard Kandavel Eye Center

Investigators

  • Principal Investigator: Ganesha R Kandavel, MD, Colvard Kandavel Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTRA-25859

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Disease (DED)

Clinical Trials on Acoltremon

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe