Dry Eye Disease (DED)Phase 4(DESERT)NCT07281950
Investigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT)
A Phase 4 study testing acoltremon 0.003% in people with Dry Eye Disease (DED), run by Center for Sight Las Vegas at 1 site in United States.
Trial summary
Dry eye disease (DED) is a common, chronic and multifactorial disease of the ocular surface presenting with signs and symptoms of ocular discomfort, visual disturbance and fluctuation, tear film instability, ocular surface inflammation and damage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- acoltremon 0.003%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 30 Nov 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults age 18 and older at Visit 1
- Have a previous history of dry eye disease, clinician diagnosed or self-reported, for at least 3 months
- Total SPEED score ≥ 6 on SPEED questionnaire at Visit 1 Screening \& Baseline
Who cannot join
- History of ocular surgery (excluding LASIK or PRK) in the past 3 months
- History of LASIK or PRK in the past 12 months
- Initiation, discontinuation or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to Visit 1 or a change in dosage is anticipated during the study.
- o Note: occasional short-term use of medications such as systemic antihistamines will be permitted provided that use was not within 24 hours of Visit 1 or anticipated use within 24 hours of any study visit.
- Active ocular infection or inflammation unrelated to dry eye disease (e.g., uveitis, blepharitis requiring antibiotics).
- Use of Restasis, Xiidra, Miebo, or any other topical anti-inflammatory medications within 30 days of Visit 1 and for the duration of the study.
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- Use of varenicline nasal spray within 30 days of Visit 1 and for the duration of the study.
- Eyelid hygiene (such as "lid scrubs") is allowed but should be continued without change to current regiment at Visit 1 Baseline for the duration of the study.
- Use of other DED medications within 30 days of Visit 1 Baseline Use of artificial tears is allowed but must be preservative free and the dosing should not change from current regiment at Visit 1 Baseline.
- Use of amniotic membranes or serum tears within 90 days of Visit 1 Baseline
- Use of lid heating therapy (i.e., LipiFlow, iLUX, TearCare) within 90 days of Visit 1 Baseline and for the duration of the study.
- Punctal or intracanalicular plug inserted in either eyelid within 90 days prior to Visit 1 Baseline or anticipated plug insertion or occlusion at any time during the study.
- Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension) or other disease the investigator believes may interfere with study findings or interpretation.
- Use of any topical ocular glaucoma medication within 30 days prior to the Screening visit or anticipated use during the study.
- Use of systemic medications that affect tear production (e.g., isotretinoin, antihistamines) unless on stable doses for > 30 days.
- Severe ocular surface disease or damage (e.g., corneal ulcers, neurotrophic keratopathy).
- Have had a corneal transplant in either or both eyes.
- Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study and unwilling to discontinue use during the duration of the study.
- Known allergy or hypersensitivity to acoltremon or formulation ingredients.
- Current pregnancy or breastfeeding
- Women of childbearing potential who are not using an acceptable means of contraception. Acceptable means of contraception include hormonal contraceptives (i.e. oral, implantable, injectable, or transdermal contraceptives, with a barrier such as a diaphragm or a condom) or intrauterine devices. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Study Coordinator contact
United States1 site
Center for Sight
Las Vegas, Nevada, 89128
Clinical Research Manager, 702-724-2005, jodi.kennedy@c4slv.com
Clinical Research Coordinator, 702-724-2067
About this study
Official title: Dry Eye Surveys to Evaluate Acoltremon in Real World Treatment (DESERT)
Dry eye disease (DED) is a common, chronic and multifactorial disease of the ocular surface presenting with signs and symptoms of ocular discomfort, visual disturbance and fluctuation, tear film instability, ocular surface inflammation and damage.
It significantly affects patients' quality of life and is one of the most frequent reasons for visits to eye care providers. Many patients remain symptomatic in real-world settings despite current pharmacologic therapeutic options available. As symptoms often lag behind ocular signs, a 3 month study with multiple time points has been designed to assess short term and mid-term symptomatic changes.
This study will use Dry Eye Surveys to evaluate Acoltremon in Real World Settings to help understand its real world effectiveness and potential to improve symptoms in dry eye patients.
Read the detailed description
TRYPTYR (Acoltremon 0.003%) is a newly FDA approved therapy for dry eye disease with a novel mechanism of action. It is a TRPM8 receptor agonist that stimulates trigeminal nerve signaling, which has been associated with increased basal tear production. As randomized clinical trials are conducted under highly controlled conditions, their results may not fully represent the effectiveness of drugs in real-world settings.
Given TRYPTYR's (Acoltremon 0.003%) recent approval, there is a need to better understand how the medication performs in real-world settings and generate real-world evidence to assess its effectiveness and impact on patient-reported symptoms in individuals with dry eye disease (DED). Real-world data is essential to evaluate treatment outcomes in routine clinical practice. The SPEED (Standard Patient Evaluation of Eye Dryness) questionnaire is a widely accepted clinical tool that captures the frequency and severity of DED symptoms from the patient's perspective. Incorporating the SPEED questionnaire into this study will enable a robust assessment of symptom burden and treatment-related changes, thereby addressing a critical unmet need in understanding TRYPTYR's real-world effectiveness and its potential to improve symptoms in DED patients.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- acoltremon 0.003%
- Keywords
- Dry Eye Disease
- 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
single arm
| Study group | Role | What they receive |
|---|---|---|
| all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon | Other | all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon 0.003% Receives: Drug: acoltremon 0.003% |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)
Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)
Measured: Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies 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
- Prospective, single-site, multi-location, single arm study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Sight Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281950
- Sponsor's protocol ID
- CFS-DESERT-102
- Acronym
- (DESERT)
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not plan to share individual participant data due to concerns about participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Eye Surveys to Evaluate Acoltremon in Real World Treatment (DESERT)
- ClinicalTrials.gov ID
- NCT07281950
- Acronym / sponsor ID
- (DESERT) / CFS-DESERT-102
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry Eye Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Center for Sight Las VegasUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Dec 2025 (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.
Dry eye disease (DED) is a common, chronic and multifactorial disease of the ocular surface presenting with signs and symptoms of ocular discomfort, visual disturbance and fluctuation, tear film instability, ocular surface inflammation and damage.
It significantly affects patients' quality of life and is one of the most frequent reasons for visits to eye care providers. Many patients remain symptomatic in real-world settings despite current pharmacologic therapeutic options available. As symptoms often lag behind ocular signs, a 3 month study with multiple time points has been designed to assess short term and mid-term symptomatic changes.
This study will use Dry Eye Surveys to evaluate Acoltremon in Real World Settings to help understand its real world effectiveness and potential to improve symptoms in dry eye patients.
Detailed description
TRYPTYR (Acoltremon 0.003%) is a newly FDA approved therapy for dry eye disease with a novel mechanism of action. It is a TRPM8 receptor agonist that stimulates trigeminal nerve signaling, which has been associated with increased basal tear production. As randomized clinical trials are conducted under highly controlled conditions, their results may not fully represent the effectiveness of drugs in real-world settings.
Given TRYPTYR's (Acoltremon 0.003%) recent approval, there is a need to better understand how the medication performs in real-world settings and generate real-world evidence to assess its effectiveness and impact on patient-reported symptoms in individuals with dry eye disease (DED). Real-world data is essential to evaluate treatment outcomes in routine clinical practice. The SPEED (Standard Patient Evaluation of Eye Dryness) questionnaire is a widely accepted clinical tool that captures the frequency and severity of DED symptoms from the patient's perspective. Incorporating the SPEED questionnaire into this study will enable a robust assessment of symptom burden and treatment-related changes, thereby addressing a critical unmet need in understanding TRYPTYR's real-world effectiveness and its potential to improve symptoms in DED patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-site, multi-location, single arm study.
| Arm | Type | Receives |
|---|---|---|
| all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon | Other | Drug: acoltremon 0.003%all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon 0.003% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adults age 18 and older at Visit 1
- Have a previous history of dry eye disease, clinician diagnosed or self-reported, for at least 3 months
- Total SPEED score ≥ 6 on SPEED questionnaire at Visit 1 Screening \& Baseline
Key exclusion criteria (21 listed)
- History of ocular surgery (excluding LASIK or PRK) in the past 3 months
- History of LASIK or PRK in the past 12 months
- Initiation, discontinuation or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to Visit 1 or a change in dosage is anticipated during the study.
- o Note: occasional short-term use of medications such as systemic antihistamines will be permitted provided that use was not within 24 hours of Visit 1 or anticipated use within 24 hours of any study visit.
- Active ocular infection or inflammation unrelated to dry eye disease (e.g., uveitis, blepharitis requiring antibiotics).
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%single arm | Drug | all subjects meeing inclusion/exclusion will be dispensed FDA Approved acoltremon |
Primary outcome
• Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)
Time frame: Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)
Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)
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 17 Dec 2025.
- Individual participant dataSharing planned: Undecided. We do not plan to share individual participant data due to concerns about participant privacy and confidentiality.
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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.
Study Coordinator 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 Disease (DED), run by Center for Sight Las Vegas 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 3 inclusion and 21 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 17 Dec 2025. 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 Clinical Research Manager (702-724-2005, jodi.kennedy@c4slv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days) (time frame: Mean Change in SPEED questionnaire score at 1 month (day 30 ± 3 days)). 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 17 Dec 2025.