Recruiting

AcoltremonEffectiveness Study of TRYPTYR in Dry Eye Disease

Sponsor:

Scott & Christie and Associates, PC

Code:

NCT07926594

Conditions

Dry Eye Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acoltremon 0.003% (TRYPTYR)

Study Details

Brief summary:

Multi-center, prospective, open-label, single-arm effectiveness of acoltremon 0.003% in improving patient signs and symptoms with dry eye disease. Subjects will be assessed at baseline, and after 7, 14, and 28 days of treatment. Clinical evaluations will include administration of the Eye Dryness Score Visual Analog Scale (EDS-VAS), measurement of visual acuity at distance, corneal fluorescein staining, conjunctival lissamine green staining, and Pain Numerical Rating Scale assessment.

Conditions

Dry Eye Disease

Study ID

NCT07926594

Start date

Oct 27, 2026

Status verified date

Nov, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed.
Be able and willing to comply with the study requirements and attend all study visits.
Be a minimum of 18 years of age of either sex and any race or ethnicity.
Diagnosis of Dry Eye Disease at least 6 months before enrollment.
Use of or desired use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection phase.
Symptoms reported on EDS-VAS >= 40 \[0-100\].
Total Corneal Fluorescein Staining of >= 7 as assessed by the NEI scale \[0-15\].
By subject report, not be pregnant or breastfeeding.

Exclusion Criteria:

Be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy.
Have known contraindications or sensitivity to the use of any of the study medications or their components.
Have an active ocular infection at Visit 1 (bacterial, viral, or fungal) in either eye, or evidence of ocular inflammation or symptomatic blepharitis, in the opinion of the investigator.
In the opinion of the investigator, at Visit 1 have any clinically significant abnormal findings in either eye that would interfere with the interpretation of the study results or subject safety.
Use of artificial tears 24 hours prior to screening, and any anticipated use throughout the study.
Use of dry eye prescription medications 30 days prior to screening and throughout the study (includes autologous serum tears, cyclosporine, lifitegrast, varenicline nasal spray, steroids etc)
Have previously used TRYPTYR (acoltremon 0.003%) ophthalmic solution in the past 6 months prior to screening
Have less than or equal to +0.6 logarithmic minimum angle of resolution (logMAR) (approximately 20/80 Snellen) distance-corrected visual acuity (DCVA) in each eye at screening.
Have completed participation in an investigational drug or drug study within 1 month of Visit 1.
Have a condition or a situation, which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Have had ocular surgical intervention (including laser procedures) of any kind within 6 months prior to Visit 1.
Contact lens wear within 14 days of Visit 1 and unwilling to discontinue contact lens wear for the study duration.
Use topical ocular medication of any kind (inclusive of LUMIFY®, LATISSE®, glaucoma medications) within 14 days of Visit 1 or throughout the study.
Be unable to demonstrate proper eyedrop instillation (using a drop of saline from a vial, in office).
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Acoltremon 0.003% (TRYPTYR)

Interventions

Acoltremon 0.003% (TRYPTYR)

1 drop per eye, twice daily (morning and evening approximately 12 hours apart), at consistent times.

Primary outcome measure

Mean change from Baseline in Eye Dryness Score Visual Analog Scale (EDS-VAS). [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Nichole Stadnik

724-772-3000 nstadnik@scottandchristie.com

Locations

Doctor My Eyes

Recruiting

Scottsdale, Arizona, United States, 85254

Contacts

Marc Bloomenstein, OD

602-708-7271 mbloomenstein@gmail.com

Scott & Christie and Associates, PC

Recruiting

Cranberry Township, Pennsylvania, United States, 16033

Contacts

Nichole Stadnik

724-772-3000 nstadnik@scottandchristie.com

Principal Investigator:

Natasha Hindman, OD

More Information

Sponsor

Scott & Christie and Associates, PC

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Scott & Christie and Associates, PC on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.