Long-term Effects of Acoltremon vs. Control in Dry Eye Disease

NCT07659626 | Not Yet Recruiting FDA Drug

• 1 other identifier: GP-26-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, longitudinal, single-center study designed to evaluate the long-term changes in symptoms and tear production in subjects with dry eye disease. The study is randomized and investigator-masked, with subjects assigned to either the TRYPTYR (Acoltremon ophthalmic solution 0.003%) arm or the control arm (Refresh Classic Preservative-free). The study will be conducted at a single site, with subjects undergoing assessments at baseline and at months 1, 3, 6, 9, and 12.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in ODS-VAS

  12 months post-treatment initiation

Other Outcomes (20)

• Mean change from baseline in unanesthetized Schirmer's test

  12 months post-treatment initiation

• Mean change from baseline in unanesthetized Schirmer's test

  9 months post-treatment initiation

• Mean change from baseline in unanesthetized Schirmer's test

  6 months post-treatment initiation

Study Arms (2)

Acoltremon 0.003%

Drug: Acoltremon 0.003%

Control

Refresh Classic Preservative free

Drug: Refresh classic preservative free

Interventions

Acoltremon 0.003% DRUG

acoltremon 0.003%

Acoltremon 0.003%

Refresh classic preservative free DRUG

Refresh classic preservative free (control)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects aged 18 years or older with a history of dry eye disease (DED) will be randomized.

You may qualify if:

• Male or female, 18 years of age or older at the Screening visit.
• Have a previous history of DED, clinician diagnosed, or patient reported, within the previous 6 months prior to the Screening visit.
• Have used, and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit.
• Both of the following signs of DED in the same eye:
• Total corneal fluorescein staining score of \>= 2 and \<= 10 based on the NEI grading scheme, with no one region scoring \> 3 in at least 1 eye.
• Unanesthetized Schirmer test score \>= 2 and \< 10 mm/5 min in at least 1 eye.
• If both eyes qualify, the eye with the lower baseline Schirmer score will be the study eye (If the Schirmer score is the same, the right eye will be the study eye).
• Symptomatic defined as an ODS-VAS score of \>=40.
• Corrected visual acuity equal to or better than logMar +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Written informed consent from the subject has been obtained prior to any study related procedures.
• Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.

You may not qualify if:

• History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
• Diagnosis of recurrent, ongoing, or active ocular infection.
• History of ocular surgery within 1 year prior to the Screening visit.
• Have had a corneal transplant in either or both eyes.
• Use of contact lenses within 2 hours of any study visit.
• Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit.
• Use of artificial tears within 24 hours of Screening visit.
• Use of any topical ocular anti-inflammatory medication or dry eye pharmaceuticals within 30 days prior to the Screening visit.
• Use of any topical ocular glaucoma medication within 30 days prior to the Screening visit.
• Change in use of any other topical ocular medication within 14 days prior to the Screening visit.
• Use of medications for the treatment of severe DED and/or Meibomian gland disease within 30 days prior to the Screening visit.
• Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying less than 14 days prior to the Screening visit.
• Use of a systemic corticosteroid less than 30 days prior to the Screening visit.
• Use of a systemic immunomodulator within 30 days prior to the Screening visit.
• Use of an investigational product or device within 30 days prior to the Screening visit.

Sponsors & Collaborators

• The Eye Care Institute: lead
• Sengi: collaborator

Study Sites (1)

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Guruprasad Pattar, MD, PhD

  Butchertown Clinical Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dani Gulock

CONTACT

(502) 219-7700; dgulock@eyecareinstitute.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 22, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)