Dry EyePhase 4NCT07848373
Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
A Phase 4 study testing acoltremon 0.003% in people with Dry Eye and Contact Lens Discomfort, run by Eye Research Associates, LLC.
Trial summary
Dry Eye Disease is a multifaceted condition which has symptoms such as eye dryness, burning, and stinging sensation in the eyes. As well as clinical diagnosis such as a decreased ability to create tear film. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Contact Lens Discomfort, Eye Drops
- What is being tested?
- acoltremon 0.003%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 21 Feb 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
- • Adult subjects who are ≥18 years of age.
- Best corrected CL visual acuity of 0.1 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/25).
- Willing to wear a new pair of CLs to the baseline study visit.
- Daily, soft, frequent replacement CL wearer (daily disposable, bi-weekly, or monthly CLs).
- An Eye Dryness VAS score of ≥40.
- CLDEQ-8 scores (CLDEQ-8 scores ≥12).
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- A score of >7 dots on the Lexitas NEI staining scale (grade 1 in a single sector on the 5-sector scale).
- Habitual wearers of soft CLs for a minimum of 5 days per week for 6 hours or more per day during the month prior to enrollment.
- Willing to maintain habitual soft CL wear of a minimum of 5 days per week for 6 or more hours per day for the 1 month duration of the study.
- Habitual CLs have an acceptable fit (good centration, movement, and coverage
Who cannot join
- Any history of acoltremon 0.003% use.
- Are currently an overnight CL wearer.
- Are currently hard or scleral CL wearers.
- Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
- Have a history of viral eye disease that may confound study results.
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- Have a history of severe ocular trauma, active ocular infection or inflammation.
- Have ever used isotretinoin-derivates (e.g., Accutane).
- Are currently taking ocular medications (including topical glaucoma medication) or plan to during the study.
- Have had a physical meibomian gland treatment withing 1 month of enrollment (iLux, Lipiflow, Radio Frequency and IPL with manual expressions, microblepharoexfoliation etc.).
- Have used a prescription DED medication in the last 1 month.
- Unwilling to agree to discontinue artificial tear use the day before enrollment and throughout the study.
- Have a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation.
- Are pregnant or breast feeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Evaluation of Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
Dry Eye Disease is a multifaceted condition which has symptoms such as eye dryness, burning, and stinging sensation in the eyes. As well as clinical diagnosis such as a decreased ability to create tear film. Despite improvements in Contact Lenses (CL) DED still is responsible for a large percentage of CL dropouts due to discomfort. Thus, the purpose of this study is to determine if acoltremon 0.003% can improve the frequency and severity of DED symptoms in CL wearers.
Read the detailed description
This 1 month 3 visit, single arm open label study aims to determine if acoltremon 0.003% can improve the frequency and severity of Dry Eye Disease (DED) symptoms in CL wearers. DED is a multifactorial condition that can cause stinging, burning sensation or dry eyes. It can also have clinically significant findings such as decreased tear production (aqueous-deficient DED) or increased tear evaporation (evaporative DED). Conditions like this often lead to discomfort, and thus individuals to drop out of wearing contact lenses. With nearly 20% of CL dropouts annually being due to discomfort.
- Conditions
- Dry Eye, Contact Lens Discomfort, Eye Drops
- 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
Acoltremon 0.003% (TRYPTYR; Alcon Laboratories; Fort Worth, TX, USA) was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin (TRPM8) agonist for the treatment of DED. Acoltremon 0.003% is dosed twice a day
| Study group | Role | What they receive |
|---|---|---|
| acoltremon 0.003% | Experimental | participants will be provided with acoltremon 0.003% and instructed to use it twice a day. Receives: Drug: acoltremon 0.003% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Dryness Score (VAS) at 4 weeks compared to baseline
participants will be asked to evaluate their eye dryness using a VAS scale with higher numbers indicating greater comfort.
Measured: 1 month
Secondary outcomes (5)
Eye Dryness Score (VAS) at 2 weeks compared to baseline
participants will be asked to complete an eye dryness visual analog scale with higher numbers indicating greater comfort
Measured: two weeks
CL End of day comfort VAS
participants will be asked to complete a contact lens comfort visual analog scale with higher numbers indicating greater comfort
Measured: 4 weeks
CL End of day comfort VAS
participants will be asked to complete a contact lens comfort visual analog scale with higher numbers indicating greater comfort
Measured: 2 weeks
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
participants will be asked to complete the CLDEQ-8 questionnaire with lower scores indicating more comfort
Measured: 1 month
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
participants will be asked to complete the CLDEQ-8 questionnaire with lower scores indicating more comfort
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion14 Feb 2027 (estimated)
- Study completion21 Feb 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
- Participants will be provided with acoltremon 0.003% and instructed to use it twice a day.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye Research Associates, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Southern College of Optometry
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848373
- Sponsor's protocol ID
- IRB000673-Acoltremon dry eye
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: An abstract describing the primary outcome will be submitted for ARVO 2027, and a manuscript on the same topic will be submitted to Contact Lens \& Anterior Eye or similar publication. An abstract related to the Likert survey results will be submitted to Optometry's Meeting 2027
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
- ClinicalTrials.gov ID
- NCT07848373
- Acronym / sponsor ID
- IRB000673-Acoltremon dry eye
- Conditions
- Dry Eye, Contact Lens Discomfort, Eye Drops
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eye Research Associates, LLCUniversity, hospital or other
- Collaborators
- Southern College of Optometry
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 21 Feb 2027 (estimated)
- First posted
- 30 Sep 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.
Dry Eye Disease is a multifaceted condition which has symptoms such as eye dryness, burning, and stinging sensation in the eyes. As well as clinical diagnosis such as a decreased ability to create tear film. Despite improvements in Contact Lenses (CL) DED still is responsible for a large percentage of CL dropouts due to discomfort. Thus, the purpose of this study is to determine if acoltremon 0.003% can improve the frequency and severity of DED symptoms in CL wearers.
Detailed description
This 1 month 3 visit, single arm open label study aims to determine if acoltremon 0.003% can improve the frequency and severity of Dry Eye Disease (DED) symptoms in CL wearers. DED is a multifactorial condition that can cause stinging, burning sensation or dry eyes. It can also have clinically significant findings such as decreased tear production (aqueous-deficient DED) or increased tear evaporation (evaporative DED). Conditions like this often lead to discomfort, and thus individuals to drop out of wearing contact lenses. With nearly 20% of CL dropouts annually being due to discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be provided with acoltremon 0.003% and instructed to use it twice a day.
| Arm | Type | Receives |
|---|---|---|
| acoltremon 0.003% | Experimental | Drug: acoltremon 0.003%participants will be provided with acoltremon 0.003% and instructed to use it twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Adult subjects who are ≥18 years of age.
Key exclusion criteria (14 listed)
- Any history of acoltremon 0.003% use.
- Are currently an overnight CL wearer.
- Are currently hard or scleral CL wearers.
- Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
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% (TRYPTYR; Alcon Laboratories; Fort Worth, TX, USA) was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin (TRPM8) agonist for the treatment of DED. Acoltremon 0.003% is dosed twice a day | Drug | acoltremon 0.003% |
Primary outcome
Eye Dryness Score (VAS) at 4 weeks compared to baseline
Time frame: 1 month
participants will be asked to evaluate their eye dryness using a VAS scale with higher numbers indicating greater comfort.
5 secondary outcomes
Eye Dryness Score (VAS) at 2 weeks compared to baseline
Time frame: two weeks
CL End of day comfort VAS
Time frame: 4 weeks
CL End of day comfort VAS
Time frame: 2 weeks
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: 1 month
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time frame: 2 weeks
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 8 Oct 2026.
- Individual participant dataSharing planned: Undecided. An abstract describing the primary outcome will be submitted for ARVO 2027, and a manuscript on the same topic will be submitted to Contact Lens \& Anterior Eye or similar publication. An abstract related to the Likert survey results will be submitted to Optometry's Meeting 2027
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acoltremon 0.003% in people with Dry Eye and Contact Lens Discomfort, run by Eye Research Associates, LLC.
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 10 inclusion and 14 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Eye Dryness Score (VAS) at 4 weeks compared to baseline (time frame: 1 month). 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 8 Oct 2026.