Dry EyePhase 4TRYPTYR ADLNCT07266948
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
A Phase 4 study testing Acoltremon in people with Dry Eye and Eye Diseases, run by Southern College of Optometry at 3 sites in United States.
Trial summary
This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dry Eye, Eye Diseases, Eyes Dry Chronic
- What is being tested?
- Acoltremon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2025to 1 Mar 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 75 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 Restasis as directed by their eye care provider for ≥1 month.
- Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms..
- Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score [≥2 to <10 mm/5 min]) at Screening/Baseline.
- Have corrected distance visual acuity of 20/100 or better.
- Willing to discontinue contact lens wear 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 or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis).
- Use of artificial tears within 2 hours prior to the baseline visit or during the study.
Show all 9Show fewer
- Are pregnant or breast feeding.
- Have had a physical meibomian gland treatment withing 1 month of enrollment.
- 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Complete Eye Care of Medina
Medina, Minnesota, 55340
Gina Wesley, OD, 763-478-3505, leahlang@cecofmedina.com
- Recruiting
The Southern College of Optometry
Memphis, Tennessee, 38104
Chris Lievens, OD, 9014815699, clievens@sco.edu
- Recruiting
Kannar Eye Care
Pittsburg, Kansas, 66762
Shane Kannarr, OD, 6202351737, skannarr@kannarreyecare.com
About this study
Official title: Evaluating the Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of <10 mm/5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20/32 (0.2 logMAR) or better.
Read the detailed description
Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly.1-3 DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED).4 Unfortunately, there is not a perfect correlation between DED signs and symptoms,5 which makes diagnosis and timely treatment challenging. With DED symptoms often being bothersome and there being a lack of universally effective treatment options,6 DED patients are significantly more likely to suffer from a decreased quality of life and a psychological condition such depression.7 Thus, the DED patient population would strongly benefit from new, innovative treatments that are based upon a novel mechanism.
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 8 (TRPM8) agonist for the treatment of DED.8 Acoltremon acts by activating TRPM8 receptors expressed on the neurons of the ophthalmic division of the trigeminal nerve, which is the nerve that innervates the cornea and eyelid.8 This drugs subsequently stimulates cold thermoreceptor to increase tear production. While acoltremon 0.003% has been significantly shown to improve tear production and symptoms as measured by the Symptom Assessment in Dry Eye (SANDE) at 14- and 28-days post-treatment, the community currently lacks data related to key measures of quality of life such as one's ability to work and perform daily tasks. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the quality of life of DED suffers
- Conditions
- Dry Eye, Eye Diseases, Eyes Dry Chronic
- Being tested
- Acoltremon
- 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.
AcoltremonDrug
Participants will be provided with Acoltremon or TRYPTYR to determine whether or not it is an effective medication to help alleviate symptoms associated with dry eye disease
| Study group | Role | What they receive |
|---|---|---|
| TRYPTYR | Experimental | Participants who qualify for the study will be given TRYPTYR to determine if it is able to help alleviate symptoms associated with dry eye disease; Receives: Drug: Acoltremon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in IDEEL-QoL Work scores at 28 days.
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
Measured: 1 month
Secondary outcomes (1)
Mean change from baseline in IDEEL-QoL Work scores at 14 days.
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
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 start1 Nov 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Mar 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Qualifying participants will be given and instructed on appropriate dosage of using Acoltremon 0.003% TRYPTYR to determine i it alleviates the symptoms associated with Dry Eye Disease
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT07266948
- Sponsor's protocol ID
- IRB00006763-ADL
- Acronym
- TRYPTYR ADL
- 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
- Individual data sharing
- Undecided
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
- Evaluating the Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
- ClinicalTrials.gov ID
- NCT07266948
- Acronym / sponsor ID
- TRYPTYR ADL / IRB00006763-ADL
- Conditions
- Dry Eye, Eye Diseases, Eyes Dry Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Mar 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.
This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of <10 mm/5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20/32 (0.2 logMAR) or better.
Detailed description
Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly.1-3 DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED).4 Unfortunately, there is not a perfect correlation between DED signs and symptoms,5 which makes diagnosis and timely treatment challenging. With DED symptoms often being bothersome and there being a lack of universally effective treatment options,6 DED patients are significantly more likely to suffer from a decreased quality of life and a psychological condition such depression.7 Thus, the DED patient population would strongly benefit from new, innovative treatments that are based upon a novel mechanism.
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 8 (TRPM8) agonist for the treatment of DED.8 Acoltremon acts by activating TRPM8 receptors expressed on the neurons of the ophthalmic division of the trigeminal nerve, which is the nerve that innervates the cornea and eyelid.8 This drugs subsequently stimulates cold thermoreceptor to increase tear production. While acoltremon 0.003% has been significantly shown to improve tear production and symptoms as measured by the Symptom Assessment in Dry Eye (SANDE) at 14- and 28-days post-treatment, the community currently lacks data related to key measures of quality of life such as one's ability to work and perform daily tasks. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the quality of life of DED suffers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Qualifying participants will be given and instructed on appropriate dosage of using Acoltremon 0.003% TRYPTYR to determine i it alleviates the symptoms associated with Dry Eye Disease
| Arm | Type | Receives |
|---|---|---|
| TRYPTYR | Experimental | Drug: AcoltremonParticipants who qualify for the study will be given TRYPTYR to determine if it is able to help alleviate symptoms associated with dry eye disease; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults ≥18 years of age.
- Have a history of DED for at least the past 6 months.
- Are currently using Restasis as directed by their eye care provider for ≥1 month.
- Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms..
- Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score [≥2 to <10 mm/5 min]) at Screening/Baseline.
Key exclusion criteria (9 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 or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis).
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 |
|---|---|---|
| AcoltremonParticipants will be provided with Acoltremon or TRYPTYR to determine whether or not it is an effective medication to help alleviate symptoms associated with dry eye disease | Drug | TRYPTYR |
Primary outcome
Mean change from baseline in IDEEL-QoL Work scores at 28 days.
Time frame: 1 month
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
1 secondary outcome
Mean change from baseline in IDEEL-QoL Work scores at 14 days.
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.
- Individual participant dataSharing planned: Undecided
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
3 sites 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 in people with Dry Eye and Eye Diseases, run by Southern College of Optometry at 3 sites 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 7 inclusion and 9 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 5 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 3 sites 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 (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?
Mean change from baseline in IDEEL-QoL Work scores at 28 days. (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 5 Dec 2025.