Recruiting

Observational Study

Sponsor:

Southern College of Optometry

Code:

NCT07266948

Conditions

Dry Eye

Eye Diseases

Eyes Dry Chronic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acoltremon

Study Details

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

Study ID

NCT07266948

Start date

Nov 1, 2025

Status verified date

Nov, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TRYPTYR

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;

Interventions

Acoltremon

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

Primary outcome measure

  • Mean change from baseline in IDEEL-QoL Work scores at 28 days. [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Chris Lievens, OD

901-722-3330clievens@sco.edu

Quentin Franklin, BS, BA

6592064188QuentinFranklin@uab.edu

Locations

Kannar Eye Care

Recruiting

Pittsburg, Kansas, United States, 66762

Contacts

Shane Kannarr, OD

6202351737skannarr@kannarreyecare.com

Complete Eye Care of Medina

Recruiting

Medina, Minnesota, United States, 55340

Contacts

Gina Wesley, OD

763-478-3505leahlang@cecofmedina.com

The Southern College of Optometry

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Chris Lievens, OD

9014815699clievens@sco.edu

More Information

Sponsor

Southern College of Optometry

Last update posted

Dec 5, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern College of Optometry on 2025-12-05.