Effectiveness Study of TRYPTYR in Dry Eye Disease

November 3, 2026 updated by: Scott & Christie and Associates, PC

A Phase IV Multicenter Evaluation of the Effectiveness of TRYPTYR in Improving Patient Signs and Symptoms With Dry Eye Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Recruiting
        • Doctor My Eyes
        • Contact:
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16033
        • Recruiting
        • Scott & Christie and Associates, PC
        • Contact:
        • Principal Investigator:
          • Natasha Hindman, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years and older with dry eye disease who present with corneal staining. Planned enrollment is 100 subjects at two sites.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Acoltremon 0.003% (TRYPTYR)
Drug: Acoltremon 0.003% (TRYPTYR)

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change from Baseline in Eye Dryness Score Visual Analog Scale (EDS-VAS).
Time Frame: 28 days
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change from Baseline in corneal fluorescein staining.
Time Frame: 28 days

Based in NEI grading scale. Five quadrants are graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome.
28 days
Mean change from Baseline in conjunctival lissamine green staining.
Time Frame: 28 days

Based in NEI grading scale. Six quadrants are graded (0-3) giving a total score (by summation) of 0-18 per eye. A higher score is a worse outcome.
28 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change from Baseline in corneal fluorescein staining.
Time Frame: 7 days

Based in NEI grading scale. Five quadrants are graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome.
7 days
Mean change from Baseline in corneal fluorescein staining.
Time Frame: 14 days

Based in NEI grading scale. Five quadrants are graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome.
14 days
Mean change from Baseline in conjunctival lissamine green staining.
Time Frame: 7 days

Based in NEI grading scale. Six quadrants are graded (0-3) giving a total score (by summation) of 0-18 per eye. A higher score is a worse outcome.
7 days
Mean change from Baseline in conjunctival lissamine green staining.
Time Frame: 14 days

Based in NEI grading scale. Six quadrants are graded (0-3) giving a total score (by summation) of 0-18 per eye. A higher score is a worse outcome.
14 days
Proportion of subjects who report at least one occurrence of ≥ 1-unit reduction compared to baseline for two consecutive recordings on the Pain Numerical Rating Scale (NRS) Assessment for instillation site sensation.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scott & Christie and Associates, PC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sengi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natasha Hindman, OD, Scott & Christie and Associates, PC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT-103984913

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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