Switching From Restasis to TRYPTYR

NCT07267299 | Not Yet Recruiting Phase 4 DMC FDA Drug

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

Brief Summary

Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.

Conditions

Dry Eye; Eye Diseases; Chronic Dry Eye

Outcome Measures

Primary Outcomes (1)

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

  schirmers strip wetting/time will be measured between pre and post drop. With quicker wetting with greater voulme being considered better.

  1 day

Secondary Outcomes (2)

• Change in SPEED scores

  28 days

• Change in SPEED scores

  14 days

Study Arms (1)

acoltremon 0.003%.

EXPERIMENTAL

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

Drug: acoltremon 0.003%

Interventions

acoltremon 0.003% DRUG

Participants who are using restasis will be switched to acoltremon 0.003%

acoltremon 0.003%.

Eligibility Criteria

• Age: 18 Years - 100 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 Restasis as directed by their eye care provider for ≥1 month.
• Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms..
• Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score \[≥2 to \<10 mm/5 min\]) at Screening/Baseline.
• Have corrected distance visual acuity of 20/100 or better.
• Willing to discontinue contact lens wear 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 or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis).
• Use of artificial tears within 2 hours prior to the baseline visit or during the study.
• Are pregnant or breast feeding.
• Have had a physical meibomian gland treatment withing 1 month of enrollment.
• 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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

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

Record last verified: 2025-11