Dry EyePhase 4NCT07901647
Evaporative Dry Eye
A Phase 4 study testing acoltremon 0.003%. in people with Dry Eye and Evaporative Dry Eye, run by Southern College of Optometry at 1 site in United States.
Trial summary
The goal of this clinical trial is to [primary purpose is to learn if accordingly, the purpose of this study is to evaluate the effects of acoltremon in participants with evaporative DED, with a focus on characterizing how symptoms and evaporative DED signs change over the first month of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Evaporative Dry Eye, Evaporative Dry Eye Disease
- What is being tested?
- acoltremon 0.003%.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2026to 1 Aug 2027
- Phase
- Phase 4
- 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
Who may be able to join
- 1. Adults ≥18 years of age. 2. Have a history of DED for at least the past 6 months. 3. Has DED as determined by the following in the study eye: TBUT ≤5 seconds plus Schirmer's test ≥5 and ≤20 mm plus a tCFS score ≥4 and ≤11 plus total MGS score ≥3.8 If Schirmer's test only qualifies for one eye, that will be the study eye. If Schirmer's test qualifies for both eyes, the eye with the lower Schirmer score will be the study eye.
- 4. Symptomatic as defined by Eye Dryness VAS score of ≥40 plus Ocular Surface Disease Index (OSDI) score ≥25 5. Have corrected distance visual acuity of 20/40 or better. 6. Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.
Who cannot join
- 1. Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- 2. Have a history of ocular surgery within the past 6 months. 3. Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- 4. Punctal plugs in place for <3 months and/or Lacrifill in place for >5 months.
- 5. Use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical glaucoma medication within the previous 30 days screening and during the study period.
- 6. Use of artificial tears within 24 hours of screening and during the study period.
- 7. Use of contact lenses within 30 days prior to screening and during the study period.
- 8. Are pregnant or breast feeding. 9. Have had a physical meibomian gland treatment withing 1 month of enrollment. 10. Initiated, discontinued, or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit.
- 11. 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Quentin X Franklin, BS, BA contact
United States1 site
The Southern College of Optometry
Memphis, Tennessee, 38104
Chris Lievens, OD, PhD, 901-481-5699, clievens@sco.edu
Quentin X Franklin, BS, BA, QuentinFranklin@uab.edu
About this study
Official title: Investigating Acoltremon 0.003% as an Evaporative Dry Eye Disease Treatment
The goal of this clinical trial is to [primary purpose is to learn if accordingly, the purpose of this study is to evaluate the effects of acoltremon in participants with evaporative DED, with a focus on characterizing how symptoms and evaporative DED signs change over the first month of treatment.
[primary hypothesis or outcome measure 1] Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1 Researchers will compare all of the enrolled participants, and everyone will be provided the same treatment.
Read more
Participants will • 2. Eye Dryness VAS: A 0-100 Eye Dryness VAS will be completed by the participants.
- 3. OSDI: The OSDI (0-100) will be completed by the subjects.
- 4. Visual Acuity: The participant's current corrected visual acuity will be measured with a high-contrast, Snellen chart. If the participant is unable to read the 20/40 letters (0.3 logMAR), the investigator will pinhole over the participant's unaided or presenting refractive error correction to determine the participant's visual potential.
- 5. Slit-Lamp Biomicroscopy: The investigator will use a slit-lamp biomicroscope to document normal and/or remarkable findings of the anterior eye structures: eyelashes, eyelids, conjunctiva, and cornea.
- Schirmer's Test without Anesthesia (Pre-Drop): Schirmer's I test will be performed on each eye for 5 minutes. The amount of wetting will be measured on each strip.
- Drop Application: 15 minutes after the pre-drop Schirmer's Test, one drop of acoltremon 0.003% will be applied to each eye.
- Schirmer's Test without Anesthesia (Post-Drop): Schirmer's I test will be performed on each eye for 5 minutes 3 minutes post-drop application. The amount of wetting will be measured on each strip.
- Tear Break Up Time (TBUT): TBUT will be determined by instilling sodium fluorescein using a strip wetted with saline (single drop and flicked to remove excess). Testing will start about 1 minute after fluorescein application. An average of three times will be utilized. A stopwatch will be used for timing.
- Total Corneal Fluorescein Staining (NEI scale): Sodium fluorescein from TBUT testing will be used to evaluate corneal fluorescein staining. After waiting for about 2-minute, corneal staining will be assessed with a cobalt blue light and a yellow filter. Corneal staining will be graded with the original National Eye Institute (NEI) grading scale; 0-3 score/region (5 regions) with 0-15 score/eye.
Meibomian Gland Secretion Score (0-15 scale): The 5 central glands on lower eyelid will be evaluated by the investigator with their finger (each scored 0-3): 0 = normal; 1 = thick/yellow; whitish, particulate; 2 = paste; 3 = none/occluded. The investigator will do their best to grade the same 5 glands each visit
Read the detailed description
Dry eye disease is a complex and multifactorial condition that impacts a large number of people around the world. Symptoms can often include burning, stinging, soreness or irritation. However clinically it is defined differently which can be described as when patients are experiencing reduced tear production (aqueous-deficient DED), increased tear evaporation (evaporative DED), or both (mixed). While many patients suffer from aqueous-deficient DED, evaporative DED is much more prevalent. Acoltremon 0.003% or TRYPTYR is designed to help stimulate TRPM8 receptors which then coordinates the secretion of aqueous from the lacrimal glands, lipids from the meibomian glands, and mucins from the goblet cells. Therefore, the goal of this study is to see if patients with evaporative dry eye disease will benefit from using Acoltremon 0.003%
- Conditions
- Dry Eye, Evaporative Dry Eye, Evaporative Dry Eye Disease
- Being tested
- acoltremon 0.003%.
- 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
Also called TRYPTYR
this study seeks to address this gap by investigating the short-term impact of acoltremon 0.003% on both symptoms and key clinical markers of evaporative DED, including tear break up time (TBUT).
| Study group | Role | What they receive |
|---|---|---|
| acoltremon 0.003% | Experimental | All participants will receive the study drug and be instructed on how to dose properly; however the bottles will be deidentified, and they will not know the product they are using to prevent biasing. Receives: Drug: acoltremon 0.003%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmers strip
Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1
Measured: baseline compared to post drop day 1
Secondary outcomes (2)
VAS Scores
Change in ocular comfort scores at 1-month compared to pre-treatment as evaluated with the Eye Dryness Visual Analog Scale (VAS).
Measured: 1 month
VAS Scores
Change in ocular comfort scores at 2 weeks compared to pre-treatment as evaluated with the Eye Dryness Visual Analog Scale (VAS).
Measured: 2 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion1 Aug 2027 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective, single-masked (participant), single-armed, study will determine how DED participants with evaporative DED signs respond to acoltremon 0.003%.
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901647
- Sponsor's protocol ID
- Evaporative Dry Eye-IRB0000676
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Acoltremon 0.003% as an Evaporative Dry Eye Disease Treatment
- ClinicalTrials.gov ID
- NCT07901647
- Acronym / sponsor ID
- Evaporative Dry Eye-IRB0000676
- Conditions
- Dry Eye, Evaporative Dry Eye, Evaporative Dry Eye Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 28 Oct 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.
The goal of this clinical trial is to [primary purpose is to learn if accordingly, the purpose of this study is to evaluate the effects of acoltremon in participants with evaporative DED, with a focus on characterizing how symptoms and evaporative DED signs change over the first month of treatment.
[primary hypothesis or outcome measure 1] Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1 Researchers will compare all of the enrolled participants, and everyone will be provided the same treatment.
Participants will • 2. Eye Dryness VAS: A 0-100 Eye Dryness VAS will be completed by the participants.
- 3. OSDI: The OSDI (0-100) will be completed by the subjects.
- 4. Visual Acuity: The participant's current corrected visual acuity will be measured with a high-contrast, Snellen chart. If the participant is unable to read the 20/40 letters (0.3 logMAR), the investigator will pinhole over the participant's unaided or presenting refractive error correction to determine the participant's visual potential.
- 5. Slit-Lamp Biomicroscopy: The investigator will use a slit-lamp biomicroscope to document normal and/or remarkable findings of the anterior eye structures: eyelashes, eyelids, conjunctiva, and cornea.
- Schirmer's Test without Anesthesia (Pre-Drop): Schirmer's I test will be performed on each eye for 5 minutes. The amount of wetting will be measured on each strip.
- Drop Application: 15 minutes after the pre-drop Schirmer's Test, one drop of acoltremon 0.003% will be applied to each eye.
- Schirmer's Test without Anesthesia (Post-Drop): Schirmer's I test will be performed on each eye for 5 minutes 3 minutes post-drop application. The amount of wetting will be measured on each strip.
- Tear Break Up Time (TBUT): TBUT will be determined by instilling sodium fluorescein using a strip wetted with saline (single drop and flicked to remove excess). Testing will start about 1 minute after fluorescein application. An average of three times will be utilized. A stopwatch will be used for timing.
- Total Corneal Fluorescein Staining (NEI scale): Sodium fluorescein from TBUT testing will be used to evaluate corneal fluorescein staining. After waiting for about 2-minute, corneal staining will be assessed with a cobalt blue light and a yellow filter. Corneal staining will be graded with the original National Eye Institute (NEI) grading scale; 0-3 score/region (5 regions) with 0-15 score/eye.
Meibomian Gland Secretion Score (0-15 scale): The 5 central glands on lower eyelid will be evaluated by the investigator with their finger (each scored 0-3): 0 = normal; 1 = thick/yellow; whitish, particulate; 2 = paste; 3 = none/occluded. The investigator will do their best to grade the same 5 glands each visit
Detailed description
Dry eye disease is a complex and multifactorial condition that impacts a large number of people around the world. Symptoms can often include burning, stinging, soreness or irritation. However clinically it is defined differently which can be described as when patients are experiencing reduced tear production (aqueous-deficient DED), increased tear evaporation (evaporative DED), or both (mixed). While many patients suffer from aqueous-deficient DED, evaporative DED is much more prevalent. Acoltremon 0.003% or TRYPTYR is designed to help stimulate TRPM8 receptors which then coordinates the secretion of aqueous from the lacrimal glands, lipids from the meibomian glands, and mucins from the goblet cells. Therefore, the goal of this study is to see if patients with evaporative dry eye disease will benefit from using Acoltremon 0.003%
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective, single-masked (participant), single-armed, study will determine how DED participants with evaporative DED signs respond to acoltremon 0.003%.
| Arm | Type | Receives |
|---|---|---|
| acoltremon 0.003% | Experimental | Drug: acoltremon 0.003%.All participants will receive the study drug and be instructed on how to dose properly; however the bottles will be deidentified, and they will not know the product they are using to prevent biasing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Adults ≥18 years of age. 2. Have a history of DED for at least the past 6 months. 3. Has DED as determined by the following in the study eye: TBUT ≤5 seconds plus Schirmer's test ≥5 and ≤20 mm plus a tCFS score ≥4 and ≤11 plus total MGS score ≥3.8 If Schirmer's test only qualifies for one eye, that will be the study eye. If Schirmer's test qualifies for both eyes, the eye with the lower Schirmer score will be the study eye.
- 4. Symptomatic as defined by Eye Dryness VAS score of ≥40 plus Ocular Surface Disease Index (OSDI) score ≥25 5. Have corrected distance visual acuity of 20/40 or better. 6. Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.
Key exclusion criteria (8 listed)
- 1. Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- 2. Have a history of ocular surgery within the past 6 months. 3. Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- 4. Punctal plugs in place for <3 months and/or Lacrifill in place for >5 months.
- 5. Use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical glaucoma medication within the previous 30 days screening and during the study period.
- 6. Use of artificial tears within 24 hours of screening and during the study period.
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%.Also: TRYPTYRthis study seeks to address this gap by investigating the short-term impact of acoltremon 0.003% on both symptoms and key clinical markers of evaporative DED, including tear break up time (TBUT). | Drug | acoltremon 0.003% |
Primary outcome
Schirmers strip
Time frame: baseline compared to post drop day 1
Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1
2 secondary outcomes
VAS Scores
Time frame: 1 month
VAS Scores
Time frame: 2 weeks compared to baseline
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 28 Oct 2026.
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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.
Quentin X Franklin, BS, BA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acoltremon 0.003%. in people with Dry Eye and Evaporative Dry Eye, run by Southern College of Optometry 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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chris Lievens, OD, PhD (901-481-5699, clievens@sco.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmers strip (time frame: baseline compared to post drop day 1). 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 28 Oct 2026.