Switching From Xiidra to TRYPTYR

NCT07267481 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB00006763-Xiidra
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%. Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Conditions

Dry Eye; Dry Eyes Chronic; Dry Eye Syndromes; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1

  The Schirmer's strip wetting time/quantity will be measured before and after the drop with quicker and more wetting me considered better.

  1 day

Secondary Outcomes (2)

• Change in standardized speed scores

  28 days

• 2 week change in standardized speed scores

  14 days

Study Arms (1)

acoltremon

EXPERIMENTAL

Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Drug: acoltremon 0.003%

Interventions

acoltremon 0.003% DRUG

Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

acoltremon

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age.
• Have a history of DED for at least the past 6 months.
• Are currently using Xiidra as directed by their eye care provider for ≥1 month.
• Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score \[≥2 to \<10 mm/5 min\]) at Screening/Baseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.
• Have corrected distance visual acuity of 20/40 or better.
• Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.

You may not qualify if:

• Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
• Have a history of ocular surgery within the past 12 months.
• Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
• Punctal plugs in place for \< 3 months and/or Lacrifill in place for \> 5 months.
• Have ever used Accutane
• Currently using ocular medications, including topical anti-inflammatory drops, (other than Xiidra) 1 month prior to enrollment
• Any artificial tear use at enrollment must remain consistent throughout the study.
• Are pregnant or breast feeding.
• Have had a physical meibomian gland treatment withing 1 month of enrollment.
• Initiated, discontinued or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit.
• Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.

Sponsors & Collaborators

• Southern College of Optometry: lead

MeSH Terms

Conditions

Dry Eye Syndromes; Eye Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases

Central Study Contacts

Chris Lievens, OD

CONTACT

901-722-3330; clievens@sco.edu

Quentin Franklin, BS, BA

CONTACT

6592064188; QuentinFranklin@uab.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective, single-masked (participant), single-armed, study will determine how participants who are being treated with Xiidra respond to acoltremon 0.003%

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: December 15, 2025
• Primary Completion: April 15, 2026
• Study Completion: May 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11