Ocular PainPhase 4AURORANCT07849803
Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain
A Phase 4 study testing acoltremon ophthalmic solution 0.003% in people with Ocular Pain and Dry Eye, run by University of South Florida at 1 site in United States.
Trial summary
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production and ocular symptoms in participants with tear deficiency and concurrent neuropathic corneal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Pain, Dry Eye
- What is being tested?
- acoltremon ophthalmic solution 0.003%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jun 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
- Male or female aged ≥ 18 years
- Baseline unanesthetized Schirmer test ≥2 and < 10 mm
- Symptoms of neuropathic corneal pain (such as burning, stinging, light sensitivity, discomfort, or pain) for at least 3 months with driving symptom rated at level 4 or higher on VAS.
- Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, MD): for decreased nerve density AND evidence of microneuromas.
- Females of childbearing potential must have a negative pregnancy test.
- Change of 50% or more improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).
Who cannot join
- Evidence of any active ocular infection or any intraocular inflammation.
- Evidence of any persistent epithelial defect/ulcer or any corneal scar/corneal edema.
- Presence of any other ocular conditions that require topical medications during the treatment phase.
- History of severe systemic allergies or severe ocular allergies.
- Inability to suspend topical medications and varenicline 8 days prior to the starting date, except for artificial and serum tears for which subjects must be stable on current regimen for ≥3 months with no changes during the trial.
- History of any ocular surgery within three months before study Visit 1.
Show all 11Show fewer
- Ocular surgery expected during the duration of the study.
- Use of refractive/therapeutic contact lenses during the study period.
- Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
- Drug addiction/alcohol abuse within the last year.
- Participation in another clinical trial concurrently.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of South Florida
Tampa, Florida, 33612
Mya Reese, 8139742020, mreese179@usf.edu
Susan Sherouse, 8139742020, ssherous@usf.edu
About this study
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production and ocular symptoms in participants with tear deficiency and concurrent neuropathic corneal pain. Acoltremon is formulated to help increase natural tear production by activating TRPM8 (Transient Receptor Potential Melastatin 8) receptors on cold-sensitive corneal nerves. It is thought that this study treatment may help participants by increasing tear production while potentially reducing neuropathic ocular symptoms, including pain and discomfort.
Participants will be followed for 8 weeks, evaluating the mean change in unanesthetized Schirmer test score between 3 minutes post-drop at Week 8 compared to pre-drop at baseline (Day 1), change in neuropathic symptom intensity as measured by a 0-10 VAS (Visual Analog Scale) from baseline to Week 8, and change in quality of life as assessed by the Ocular Pain Assessment Survey (OPAS) from baseline to Week 8. The study will also evaluate changes in corneal nerve structure, nerve function, corneal sensitivity, ocular surface symptoms, and treatment satisfaction.
Read the detailed description
AURORA is a prospective, open-label, single-center, single-arm investigator-initiated study evaluating TRYPTYR (acoltremon ophthalmic solution 0.003%) in 28 adults with neuropathic corneal pain and concurrent tear deficiency. Eligible participants must have neuropathic ocular symptoms for at least 3 months, a driving symptom score of at least 4 on a 0-10 VAS (Visual Analog Scale), reduced corneal nerve density and microneuromas on IVCM (In Vivo Confocal Microscopy), at least 50% symptom improvement following topical proparacaine, and an unanesthetized Schirmer score of at least 2 mm but less than 10 mm.
Participants will administer acoltremon 0.003% in both eyes twice daily for 8 weeks. One qualifying eye per participant will be designated as the study eye for analysis. There is no placebo or comparator group.
The primary endpoint is the mean change in unanesthetized Schirmer score from pre-drop baseline to 3 minutes post-drop at Week 8. Secondary endpoints include acute change in Schirmer score on Day 1, change in neuropathic ocular symptom intensity on the VAS (Visual Analog Scale), and change in quality of life measured by OPAS (Ocular Pain Assessment Survey). Exploratory outcomes include changes in corneal nerve structure and function, corneal sensitivity, OSDI (Ocular Surface Disease Index) scores, drop comfort, and treatment satisfaction.
Safety monitoring will focus on corneal staining, visual acuity, discomfort following drop administration, and adverse events, with a safety assessment conducted after the first five participants.
- Conditions
- Ocular Pain, Dry Eye
- Being tested
- acoltremon ophthalmic solution 0.003%
- Keywords
- Dry Eye, Eye pain, tear deficiency
- Medical subject headings
- Eye Pain, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoltremon ophthalmic solution 0.003%Drug
acoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acoltremon Group | Experimental | Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks. Receives: Drug: acoltremon ophthalmic solution 0.003% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unanesthetized Schirmer Test Score at Week 8
Mean change from the pre-dose measurement at baseline (Day 1) to the measurement taken 3 minutes after dosing at Week 8. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome.
Measured: Time frame: Baseline to Week 8
Secondary outcomes (3)
Acute Change in Unanesthetized Schirmer Test Score on Day 1
Mean change from the pre-dose measurement to the measurement taken 3 minutes after the first dose. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome.
Measured: Pre-dose to 3 minutes post-dose on Day 1
Change in Neuropathic Ocular Symptom Intensity
Change in pain, discomfort, or another identified neuropathic symptom measured using a 0-10 visual analog scale (VAS). Range: 0-10 Interpretation: Higher scores indicate greater pain or symptom severity and a worse outcome.
Measured: Baseline to Week 8
Change in Ocular Pain-Related Quality of Life
Change in quality of life measured using the Ocular Pain Assessment Survey (OPAS). Range: 0-10 Interpretation: Higher scores indicate greater ocular pain and symptom severity and a worse outcome.
Measured: Baseline to Week 8
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 startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ocular PainStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, University of South Florida/Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849803
- Sponsor's protocol ID
- RTI #26-RCD0.16
- Acronym
- AURORA
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The University of South Florida Eye Institute is not a pharmacy distribution company, the information being collected is for medical science to improve patient care options.
Publications
Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
PubMed 16697110Villani E, Baudouin C, Efron N, Hamrah P, Kojima T, Patel SV, Pflugfelder SC, Zhivov A, Dogru M. In vivo confocal microscopy of the ocular surface: from bench to bedside. Curr Eye Res. 2014 Mar;39(3):213-31. doi: 10.3109/02713683.2013.842592. Epub 2013 Nov 11.
PubMed 24215436Qazi Y, Hurwitz S, Khan S, Jurkunas UV, Dana R, Hamrah P. Validity and Reliability of a Novel Ocular Pain Assessment Survey (OPAS) in Quantifying and Monitoring Corneal and Ocular Surface Pain. Ophthalmology. 2016 Jul;123(7):1458-68. doi: 10.1016/j.ophtha.2016.03.006. Epub 2016 Apr 16.
PubMed 27089999Dieckmann G, Goyal S, Hamrah P. Neuropathic Corneal Pain: Approaches for Management. Ophthalmology. 2017 Nov;124(11S):S34-S47. doi: 10.1016/j.ophtha.2017.08.004.
PubMed 29055360Galor A, Levitt RC, Felix ER, Martin ER, Sarantopoulos CD. Neuropathic ocular pain: an important yet underevaluated feature of dry eye. Eye (Lond). 2015 Mar;29(3):301-12. doi: 10.1038/eye.2014.263. Epub 2014 Nov 7.
PubMed 25376119Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.
PubMed 28736339Marfurt C, Anokwute MC, Fetcko K, Mahony-Perez E, Farooq H, Ross E, Baumanis MM, Weinberg RL, McCarron ME, Mankowski JL. Comparative Anatomy of the Mammalian Corneal Subbasal Nerve Plexus. Invest Ophthalmol Vis Sci. 2019 Dec 2;60(15):4972-4984. doi: 10.1167/iovs.19-28519.
PubMed 31790560Cruzat A, Qazi Y, Hamrah P. In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease. Ocul Surf. 2017 Jan;15(1):15-47. doi: 10.1016/j.jtos.2016.09.004. Epub 2016 Oct 19.
PubMed 27771327Marfurt CF, Cox J, Deek S, Dvorscak L. Anatomy of the human corneal innervation. Exp Eye Res. 2010 Apr;90(4):478-92. doi: 10.1016/j.exer.2009.12.010. Epub 2009 Dec 29.
PubMed 20036654
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain
- ClinicalTrials.gov ID
- NCT07849803
- Acronym / sponsor ID
- AURORA / RTI #26-RCD0.16
- Conditions
- Ocular Pain, Dry Eye
- Keywords
- Dry Eye, Eye pain, tear deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 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.
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production and ocular symptoms in participants with tear deficiency and concurrent neuropathic corneal pain. Acoltremon is formulated to help increase natural tear production by activating TRPM8 (Transient Receptor Potential Melastatin 8) receptors on cold-sensitive corneal nerves. It is thought that this study treatment may help participants by increasing tear production while potentially reducing neuropathic ocular symptoms, including pain and discomfort.
Participants will be followed for 8 weeks, evaluating the mean change in unanesthetized Schirmer test score between 3 minutes post-drop at Week 8 compared to pre-drop at baseline (Day 1), change in neuropathic symptom intensity as measured by a 0-10 VAS (Visual Analog Scale) from baseline to Week 8, and change in quality of life as assessed by the Ocular Pain Assessment Survey (OPAS) from baseline to Week 8. The study will also evaluate changes in corneal nerve structure, nerve function, corneal sensitivity, ocular surface symptoms, and treatment satisfaction.
Detailed description
AURORA is a prospective, open-label, single-center, single-arm investigator-initiated study evaluating TRYPTYR (acoltremon ophthalmic solution 0.003%) in 28 adults with neuropathic corneal pain and concurrent tear deficiency. Eligible participants must have neuropathic ocular symptoms for at least 3 months, a driving symptom score of at least 4 on a 0-10 VAS (Visual Analog Scale), reduced corneal nerve density and microneuromas on IVCM (In Vivo Confocal Microscopy), at least 50% symptom improvement following topical proparacaine, and an unanesthetized Schirmer score of at least 2 mm but less than 10 mm.
Participants will administer acoltremon 0.003% in both eyes twice daily for 8 weeks. One qualifying eye per participant will be designated as the study eye for analysis. There is no placebo or comparator group.
The primary endpoint is the mean change in unanesthetized Schirmer score from pre-drop baseline to 3 minutes post-drop at Week 8. Secondary endpoints include acute change in Schirmer score on Day 1, change in neuropathic ocular symptom intensity on the VAS (Visual Analog Scale), and change in quality of life measured by OPAS (Ocular Pain Assessment Survey). Exploratory outcomes include changes in corneal nerve structure and function, corneal sensitivity, OSDI (Ocular Surface Disease Index) scores, drop comfort, and treatment satisfaction.
Safety monitoring will focus on corneal staining, visual acuity, discomfort following drop administration, and adverse events, with a safety assessment conducted after the first five participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acoltremon Group | Experimental | Drug: acoltremon ophthalmic solution 0.003%Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged ≥ 18 years
- Baseline unanesthetized Schirmer test ≥2 and < 10 mm
- Symptoms of neuropathic corneal pain (such as burning, stinging, light sensitivity, discomfort, or pain) for at least 3 months with driving symptom rated at level 4 or higher on VAS.
- Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, MD): for decreased nerve density AND evidence of microneuromas.
- Females of childbearing potential must have a negative pregnancy test.
Key exclusion criteria (11 listed)
- Evidence of any active ocular infection or any intraocular inflammation.
- Evidence of any persistent epithelial defect/ulcer or any corneal scar/corneal edema.
- Presence of any other ocular conditions that require topical medications during the treatment phase.
- History of severe systemic allergies or severe ocular allergies.
- Inability to suspend topical medications and varenicline 8 days prior to the starting date, except for artificial and serum tears for which subjects must be stable on current regimen for ≥3 months with no changes during the trial.
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 ophthalmic solution 0.003%acoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks. | Drug | Acoltremon Group |
Primary outcome
Change in Unanesthetized Schirmer Test Score at Week 8
Time frame: Time frame: Baseline to Week 8
Mean change from the pre-dose measurement at baseline (Day 1) to the measurement taken 3 minutes after dosing at Week 8. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome.
3 secondary outcomes
Acute Change in Unanesthetized Schirmer Test Score on Day 1
Time frame: Pre-dose to 3 minutes post-dose on Day 1
Change in Neuropathic Ocular Symptom Intensity
Time frame: Baseline to Week 8
Change in Ocular Pain-Related Quality of Life
Time frame: Baseline to Week 8
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 6 Oct 2026.
- Background: PubMed 16697110Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
- Background: PubMed 24215436Villani E, Baudouin C, Efron N, Hamrah P, Kojima T, Patel SV, Pflugfelder SC, Zhivov A, Dogru M. In vivo confocal microscopy of the ocular surface: from bench to bedside. Curr Eye Res. 2014 Mar;39(3):213-31. doi: 10.3109/02713683.2013.842592. Epub 2013 Nov 11.
- Background: PubMed 27089999Qazi Y, Hurwitz S, Khan S, Jurkunas UV, Dana R, Hamrah P. Validity and Reliability of a Novel Ocular Pain Assessment Survey (OPAS) in Quantifying and Monitoring Corneal and Ocular Surface Pain. Ophthalmology. 2016 Jul;123(7):1458-68. doi: 10.1016/j.ophtha.2016.03.006. Epub 2016 Apr 16.
- Background: PubMed 29055360Dieckmann G, Goyal S, Hamrah P. Neuropathic Corneal Pain: Approaches for Management. Ophthalmology. 2017 Nov;124(11S):S34-S47. doi: 10.1016/j.ophtha.2017.08.004.
- Background: PubMed 25376119Galor A, Levitt RC, Felix ER, Martin ER, Sarantopoulos CD. Neuropathic ocular pain: an important yet underevaluated feature of dry eye. Eye (Lond). 2015 Mar;29(3):301-12. doi: 10.1038/eye.2014.263. Epub 2014 Nov 7.
- Background: PubMed 28736339Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.
- Background: PubMed 31790560Marfurt C, Anokwute MC, Fetcko K, Mahony-Perez E, Farooq H, Ross E, Baumanis MM, Weinberg RL, McCarron ME, Mankowski JL. Comparative Anatomy of the Mammalian Corneal Subbasal Nerve Plexus. Invest Ophthalmol Vis Sci. 2019 Dec 2;60(15):4972-4984. doi: 10.1167/iovs.19-28519.
- Background: PubMed 27771327Cruzat A, Qazi Y, Hamrah P. In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease. Ocul Surf. 2017 Jan;15(1):15-47. doi: 10.1016/j.jtos.2016.09.004. Epub 2016 Oct 19.
- Background: PubMed 20036654Marfurt CF, Cox J, Deek S, Dvorscak L. Anatomy of the human corneal innervation. Exp Eye Res. 2010 Apr;90(4):478-92. doi: 10.1016/j.exer.2009.12.010. Epub 2009 Dec 29.
- Individual participant dataSharing planned: No. The University of South Florida Eye Institute is not a pharmacy distribution company, the information being collected is for medical science to improve patient care options.
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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.
Pedram Hamrah, MD principal investigator
University of South Florida/Ophthalmology
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 ophthalmic solution 0.003% in people with Ocular Pain and Dry Eye, run by University of South Florida 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 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 6 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 Mya L. Reese (18139742020, MCOM-Eyeresearch@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Unanesthetized Schirmer Test Score at Week 8 (time frame: Time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07849803, which also lists 9 linked publications.
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 6 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.