Dry EyePhase 4NCT07267481
Switching From Xiidra to TRYPTYR
A Phase 4 study testing acoltremon 0.003% in people with Dry Eye and Dry Eyes Chronic, run by Southern College of Optometry.
Trial summary
To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%. Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes
- What is being tested?
- acoltremon 0.003%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 1 May 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age.
- Have a history of DED for at least the past 6 months.
- Are currently using Xiidra as directed by their eye care provider for ≥1 month.
- Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score [≥2 to <10 mm/5 min]) at Screening/Baseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.
- Have corrected distance visual acuity of 20/40 or better.
- Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.
Who cannot join
- Have a systemic health condition that is 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 severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- Punctal plugs in place for < 3 months and/or Lacrifill in place for > 5 months.
- Have ever used Accutane
- Currently using ocular medications, including topical anti-inflammatory drops, (other than Xiidra) 1 month prior to enrollment
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- Any artificial tear use at enrollment must remain consistent throughout the study.
- Are pregnant or breast feeding.
- Have had a physical meibomian gland treatment withing 1 month of enrollment.
- 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.
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Switching Participants Treated With Xiidra to TRYPTYR
To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%.
Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.
Read the detailed description
This prospective, single-masked (participant), single-armed, study will determine how participants who are being treated with Xiidra respond to acoltremon 0.003%. Pre- to post-drop Schirmer's test scores at Day 1 will be the primary outcome. Some studies found the Day 1 mean differences for pre- to post-drop Schirmer's test score was 8.9, and the 28 Day mean differences for pre- to post-drop Schirmer's test score was 10.6 0.58 mm. If one assumes a clinically meaningful difference of 3 units (SD = 0.58; α of 0.05 and power of 80%), a total of 3 subjects will be needed to determine if there is a significant change in pre- to post-drop Schirmer's test scores. SPEED questionnaire at Days 14 and 28 will be the secondary outcomes. SPEED questionnaire scores of 2.2, 5.0, 6.6, and 9.9 corresponded to having asymptomatic, mild, moderate, and severe dry eye symptoms, and as such a 3 unit change will be considered to be a clinically meaningful difference.11 Asiedu et al. found that the typical subject with moderate dry eye has a mean SD SPEED score of 6.6 , which is the target symptoms severity level of this study.11 If one assumes a clinically meaningful difference of 3 units (SD = 4.1; α of 0.05 and power of 80%), a total of 17 subjects will be needed to determine if there is a significant change in SPEED scores at day 14 or 28. Exploratory outcomes include Likert survey questions; thus, the overall sample size will be inflated to 100 participants to help ensure that representative survey responses are obtained from the participants included in this study.
- Conditions
- Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes, Eye Diseases
- Being tested
- acoltremon 0.003%
- Medical subject headings
- Dry Eye Syndromes, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoltremon 0.003%Drug
Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.
| Study group | Role | What they receive |
|---|---|---|
| acoltremon | Experimental | Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline. Receives: Drug: acoltremon 0.003% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1
The Schirmer's strip wetting time/quantity will be measured before and after the drop with quicker and more wetting me considered better.
Measured: 1 day
Secondary outcomes (2)
Change in standardized speed scores
The standardized speed scores will be measured to determine change from baseline to 28 days with lower scores being better.
Measured: 28 days
2 week change in standardized speed scores
The standardized speed scores will be measured to determine change from baseline to 14 days with lower scores being better.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion1 May 2026 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective, single-masked (participant), single-armed, study will determine how participants who are being treated with Xiidra respond to acoltremon 0.003%
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267481
- Sponsor's protocol ID
- IRB00006763-Xiidra
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Switching Participants Treated With Xiidra to TRYPTYR
- ClinicalTrials.gov ID
- NCT07267481
- Acronym / sponsor ID
- IRB00006763-Xiidra
- Conditions
- Dry Eye, Dry Eyes Chronic, Dry Eye Syndromes, Eye Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 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.
To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%.
Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.
Detailed description
This prospective, single-masked (participant), single-armed, study will determine how participants who are being treated with Xiidra respond to acoltremon 0.003%. Pre- to post-drop Schirmer's test scores at Day 1 will be the primary outcome. Some studies found the Day 1 mean differences for pre- to post-drop Schirmer's test score was 8.9, and the 28 Day mean differences for pre- to post-drop Schirmer's test score was 10.6 0.58 mm. If one assumes a clinically meaningful difference of 3 units (SD = 0.58; α of 0.05 and power of 80%), a total of 3 subjects will be needed to determine if there is a significant change in pre- to post-drop Schirmer's test scores. SPEED questionnaire at Days 14 and 28 will be the secondary outcomes. SPEED questionnaire scores of 2.2, 5.0, 6.6, and 9.9 corresponded to having asymptomatic, mild, moderate, and severe dry eye symptoms, and as such a 3 unit change will be considered to be a clinically meaningful difference.11 Asiedu et al. found that the typical subject with moderate dry eye has a mean SD SPEED score of 6.6 , which is the target symptoms severity level of this study.11 If one assumes a clinically meaningful difference of 3 units (SD = 4.1; α of 0.05 and power of 80%), a total of 17 subjects will be needed to determine if there is a significant change in SPEED scores at day 14 or 28. Exploratory outcomes include Likert survey questions; thus, the overall sample size will be inflated to 100 participants to help ensure that representative survey responses are obtained from the participants included in this study.
Study design
- Primary purpose
- Other
- 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 participants who are being treated with Xiidra respond to acoltremon 0.003%
| Arm | Type | Receives |
|---|---|---|
| acoltremon | Experimental | Drug: acoltremon 0.003%Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥18 years of age.
- Have a history of DED for at least the past 6 months.
- Are currently using Xiidra as directed by their eye care provider for ≥1 month.
- Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score [≥2 to <10 mm/5 min]) at Screening/Baseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.
- Have corrected distance visual acuity of 20/40 or better.
Key exclusion criteria (11 listed)
- Have a systemic health condition that is 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 severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- Punctal plugs in place for < 3 months and/or Lacrifill in place for > 5 months.
- Have ever used Accutane
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%Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline. | Drug | acoltremon |
Primary outcome
Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1
Time frame: 1 day
The Schirmer's strip wetting time/quantity will be measured before and after the drop with quicker and more wetting me considered better.
2 secondary outcomes
Change in standardized speed scores
Time frame: 28 days
2 week change in standardized speed scores
Time frame: 14 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 5 Dec 2025.
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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 Dry Eyes Chronic, run by Southern College of Optometry.
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 6 inclusion and 11 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 5 Dec 2025. 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 (901-722-3330, clievens@sco.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1 (time frame: 1 day). 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 5 Dec 2025.