ClinicalTrials.gg
RecruitingNCT07926594Updated Nov 9, 2026

Effectiveness Study of TRYPTYR in Dry Eye Disease

An observational study in Dry Eye Disease, sponsored by Scott & Christie and Associates, PC. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Scott & Christie and Associates, PC · Observational

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 542 studies in Dry Eye Syndromes with a site in United States — 51 open to participants now, 61 under way, 3 of them phase 3. Dry Eye Syndromes · United States.

Planned enrollment
27th of 63
100 · median 80
Started
2026
with 33 others
Observational
63 of 542
10 open now
Primary completion
2027-06
later than 43 of 60 live
Registered
540th of 542
by date

Among the 542 studies in Dry Eye Syndromes with a site in United States, this one is the 27th largest by planned enrollment of the 63 observational ones that give a count, is one of 34 that started in 2026, is one of 63 observational ones, reaches primary completion later than 43 of the 60 other live ones, and was the 540th registered.

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

Browse Dry Eye Syndromes studies →

Open to participants now

51 of the 542 studies in Dry Eye Syndromes with a site in United States are open now. Recruiting first, the newest first:

45 more — sign in →

All 51 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 542 studies in Dry Eye Syndromes with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Dry Eye Disease

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be able and willing to provide written 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

Exclusion Criteria:

  • Be a female of who is currently pregnant, nursing, or planning a pregnancy.
  • Have known 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 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, 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acoltremon 0.003% (TRYPTYR)

    Drug: Acoltremon 0.003% (TRYPTYR)

Interventions

  • DrugAcoltremon 0.003% (TRYPTYR)

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

06

What researchers measure

Primary outcomes

  1. Mean change from Baseline in Eye Dryness Score Visual Analog Scale (EDS-VAS).

    Time frame: 28 days

Secondary outcomes

  1. Mean change from Baseline in corneal fluorescein staining.

    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.

    Time frame: 28 days

  2. Mean change from Baseline in conjunctival lissamine green staining.

    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.

    Time frame: 28 days

Other outcomes

  1. Mean change from Baseline in corneal fluorescein staining.

    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.

    Time frame: 7 days

  2. Mean change from Baseline in corneal fluorescein staining.

    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.

    Time frame: 14 days

  3. Mean change from Baseline in conjunctival lissamine green staining.

    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.

    Time frame: 7 days

  4. Mean change from Baseline in conjunctival lissamine green staining.

    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.

    Time frame: 14 days

  5. 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

07

Study locations

2 of 2 sites recruiting
  • Doctor My Eyes
    Scottsdale, Arizona 85254, United States
    Recruiting
  • Scott & Christie and Associates, PC
    Cranberry Township, Pennsylvania 16033, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.

Of 53 non-industry observational studies under Dry Eye Syndromes, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 64. This study's planned 8 months is below that.

Counting every sponsor, half of 69 studies reached it within 12 months; a quarter within 5 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 9, 2026
StartActual
Oct 27, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07926594
Lead sponsor
Scott & Christie and Associates, PC
Collaborators
Sengi
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Oct 27, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Nichole Stadnik
Contact
nstadnik@scottandchristie.com
724-772-3000
Natasha Hindman, OD
principal investigator · Scott & Christie and Associates, PC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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