Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work

NCT07266948 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB00006763-ADL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of \<10 mm/5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20/32 (0.2 logMAR) or better.

Conditions

Dry Eye; Eye Diseases; Eyes Dry Chronic

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in IDEEL-QoL Work scores at 28 days.

  the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr

  1 month

Secondary Outcomes (1)

• Mean change from baseline in IDEEL-QoL Work scores at 14 days.

  14 days

Study Arms (1)

TRYPTYR

EXPERIMENTAL

Participants who qualify for the study will be given TRYPTYR to determine if it is able to help alleviate symptoms associated with dry eye disease;

Drug: Acoltremon

Interventions

Acoltremon DRUG

Participants will be provided with Acoltremon or TRYPTYR to determine whether or not it is an effective medication to help alleviate symptoms associated with dry eye disease

TRYPTYR

Eligibility Criteria

• Age: 18 Years - 75 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

Study Sites (3)

Kannar Eye Care

Pittsburg, Kansas, 66762, United States

RECRUITING

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

RECRUITING

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

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: Qualifying participants will be given and instructed on appropriate dosage of using Acoltremon 0.003% TRYPTYR to determine i it alleviates the symptoms associated with Dry Eye Disease

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: November 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

US (3)