Dry EyeNCT07659626
Long-term Effects of Acoltremon vs. Control in Dry Eye Disease
An observational study of Dry Eye, run by The Eye Care Institute at 1 site in United States.
Trial summary
This is a prospective, longitudinal, single-center study designed to evaluate the long-term changes in symptoms and tear production in subjects with dry eye disease. The study is randomized and investigator-masked, with subjects assigned to either the TRYPTYR (Acoltremon ophthalmic solution 0.003%) arm or the control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Acoltremon 0.003% and Refresh classic preservative free
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2026to 20 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged 18 years or older with a history of dry eye disease (DED) will be randomized.
Who may be able to join
- Male or female, 18 years of age or older at the Screening visit.
- Have a previous history of DED, clinician diagnosed, or patient reported, within the previous 6 months prior to the Screening visit.
- Have used, and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit.
- Both of the following signs of DED in the same eye:
- Total corneal fluorescein staining score of >= 2 and <= 10 based on the NEI grading scheme, with no one region scoring > 3 in at least 1 eye.
- Unanesthetized Schirmer test score >= 2 and < 10 mm/5 min in at least 1 eye.
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- If both eyes qualify, the eye with the lower baseline Schirmer score will be the study eye (If the Schirmer score is the same, the right eye will be the study eye).
- Symptomatic defined as an ODS-VAS score of >=40.
- Corrected visual acuity equal to or better than logMar +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Written informed consent from the subject has been obtained prior to any study related procedures.
- Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.
Who cannot join
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
- Diagnosis of recurrent, ongoing, or active ocular infection.
- History of ocular surgery within 1 year prior to the Screening visit.
- Have had a corneal transplant in either or both eyes.
- Use of contact lenses within 2 hours of any study visit.
- Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit.
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- Use of artificial tears within 24 hours of Screening visit.
- Use of any topical ocular anti-inflammatory medication or dry eye pharmaceuticals within 30 days prior to the Screening visit.
- Use of any topical ocular glaucoma medication within 30 days prior to the Screening visit.
- Change in use of any other topical ocular medication within 14 days prior to the Screening visit.
- Use of medications for the treatment of severe DED and/or Meibomian gland disease within 30 days prior to the Screening visit.
- Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying less than 14 days prior to the Screening visit.
- Use of a systemic corticosteroid less than 30 days prior to the Screening visit.
- Use of a systemic immunomodulator within 30 days prior to the Screening visit.
- Use of an investigational product or device within 30 days prior to the Screening visit.
- At the Screening visit, have uncontrolled or severe systemic allergy, rhinitis or sinusitis.
- History or presence of significant systemic disease.
- Known allergies or sensitivity to the study interventions or study diagnostic agents.
- Women of childbearing potential who are not using a medically acceptable form of birth control.
- The subject has a condition or is in a situation that, in the Investigator's opinion, may put the subject at significant risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Dani Gulock, 502-219-7700, dgulock@eyecareinstitute.com
Guruprasad Pattar, MD, PhD
About this study
Official title: A Randomized, Investigator-masked, Longitudinal Study Evaluating Long-term Changes in Symptoms and Tear Production of Acoltremon Ophthalmic Solution 0.003% Compared to Control in Subjects With Dry Eye Disease
This is a prospective, longitudinal, single-center study designed to evaluate the long-term changes in symptoms and tear production in subjects with dry eye disease. The study is randomized and investigator-masked, with subjects assigned to either the TRYPTYR (Acoltremon ophthalmic solution 0.003%) arm or the control arm (Refresh Classic Preservative-free). The study will be conducted at a single site, with subjects undergoing assessments at baseline and at months 1, 3, 6, 9, and 12.
- Conditions
- Dry Eye
- Being tested
- Acoltremon 0.003%, Refresh classic preservative free
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoltremon 0.003%Drug
acoltremon 0.003%
Refresh classic preservative freeDrug
Refresh classic preservative free (control)
| Study group | Role | What they receive |
|---|---|---|
| Acoltremon 0.003% | Not described Receives: Drug: Acoltremon 0.003% | |
| Control | Refresh Classic Preservative free Receives: Drug: Refresh classic preservative free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in ODS-VAS
Measured: 12 months post-treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start18 Aug 2026
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Care Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Guruprasad Pattar, MD, PhD, Principal investigator, Butchertown Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659626
- Sponsor's protocol ID
- GP-26-01
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator-masked, Longitudinal Study Evaluating Long-term Changes in Symptoms and Tear Production of Acoltremon Ophthalmic Solution 0.003% Compared to Control in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07659626
- Acronym / sponsor ID
- GP-26-01
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Eye Care InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2029 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, longitudinal, single-center study designed to evaluate the long-term changes in symptoms and tear production in subjects with dry eye disease. The study is randomized and investigator-masked, with subjects assigned to either the TRYPTYR (Acoltremon ophthalmic solution 0.003%) arm or the control arm (Refresh Classic Preservative-free). The study will be conducted at a single site, with subjects undergoing assessments at baseline and at months 1, 3, 6, 9, and 12.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acoltremon 0.003% | – | Drug: Acoltremon 0.003% |
| Control | – | Drug: Refresh classic preservative freeRefresh Classic Preservative free |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 18 years or older with a history of dry eye disease (DED) will be randomized.
Key inclusion criteria (12 listed)
- Male or female, 18 years of age or older at the Screening visit.
- Have a previous history of DED, clinician diagnosed, or patient reported, within the previous 6 months prior to the Screening visit.
- Have used, and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit.
- Both of the following signs of DED in the same eye:
- Symptomatic defined as an ODS-VAS score of >=40.
Key exclusion criteria (20 listed)
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety.
- Diagnosis of recurrent, ongoing, or active ocular infection.
- History of ocular surgery within 1 year prior to the Screening visit.
- Have had a corneal transplant in either or both eyes.
- Use of contact lenses within 2 hours of any study visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoltremon 0.003%acoltremon 0.003% | Drug | Acoltremon 0.003% |
| Refresh classic preservative freeRefresh classic preservative free (control) | Drug | Control |
Primary outcome
Mean change from baseline in ODS-VAS
Time frame: 12 months post-treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guruprasad Pattar, MD, PhD principal investigator
Butchertown Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by The Eye Care Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dani Gulock ((502) 219-7700, dgulock@eyecareinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in ODS-VAS (time frame: 12 months post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.