Loading clinical trials...

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

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

NCT07268599•Colvard Kandavel Eye Center

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.

Eligibility

Age

18 - 60 years

Sex

ALL

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
+6 more criteria

Locations (1)

Colvard-Kandavel Eye Center

Encino, California, United States

Key Dates

Start Date

November 24, 2025

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

December 8, 2025

Enrollment

ESTIMATED participants

Conditions

Dry Eye Disease (DED)

Interventions

Acoltremon

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITINGPHASE4

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

NCT07396441

Juvenile Open Angle GlaucomaDry Eye Disease (DED)+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Role of Corneal Nerves in Dry Eye Disease

Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT

A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction