Ocular Surface DiseasePhase 4NCT07502378
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
A Phase 4 study testing Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. in people with Ocular Surface Disease and Neurotrophic Keratopathy Stage 1, run by University of South Florida at 1 site in United States.
Trial summary
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Disease, Neurotrophic Keratopathy Stage 1
- What is being tested?
- Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2026to 31 Aug 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
- Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal sensation (Cochet-Bonnet less than 4cm in the central cornea)
- Baseline unanesthetized Schirmer's test ≤ 10 mm
- Females of childbearing potential must have a negative pregnancy test.
- Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200).
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 8 days prior to the starting date and artificial tears 2 hours prior to the first study visit and remain off for the duration of the study.
- History of any ocular surgery within three months before study visit 1.
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- 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.
- 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, 1 recruiting
- Recruiting
University of South Florida/Ophthalmology
Tampa, Florida, 33612
Angie Windham, 813-974-1423, angiewindham@usf.edu
Susan Sherouse, 813-974-0948, ssherous@usf.edu
About this study
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
Read the detailed description
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production in subjects with stage I neurotrophic keratopathy (NK). The study drug, Acoltremon, is formulated to help increase tear production. Since the tissue breakdown of the cornea is causing NK, it is thought that this study treatment may help participants with this disease by enhancing wound healing, repair and regeneration through improving nerve function of the cornea.
Participants will be followed for 8 weeks, evaluating unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1), their mean change in Best Corrected distance visual acuity (ETDRS standards) from day 1 to week 8, and change in central corneal staining from baseline to week 8.
- Being tested
- Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period., Alternative would be patient exiting the trial and starting on tears or other standard of care.
- Keywords
- Ocular Surface Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.Drug
This is an FDA approved drug. The participants will be educated on the potential instillation site sensation that may occur as reported from the Pivotal Trials and that the sensation may differ between eyes due to the Neurotrophic Keratopathy.
Qualified eyes must meet the inclusion and exclusion criteria. If both eyes qualify, then the one with the worst vision will be the study eye. If both eyes have equal visual acuity then the right eye will be the study eye.
Alternative would be patient exiting the trial and starting on tears or other standard of care.Other
This is an open label trial. If the patient does not do well on Acoltremon Ophthalmic Solution, then the participant will be removed from trial and put on standard of care treatment, other than Acoltremon.
| Study group | Role | What they receive |
|---|---|---|
| Acoltremon 0.003% Ophthalmic Solution | Other | Open Label treatment of Acoltremon Receives: Drug: Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.; Other: Alternative would be patient exiting the trial and starting on tears or other standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unanesthetized Schirmer Test
Mean change in unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1)
Measured: 8 weeks
Secondary outcomes (1)
Unanesthetized Schirmer test
Mean change in unanesthetized Schirmer test score between 3 mins post-drop day 1 compared to pre-drop at day 1.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start6 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ocular Surface DiseaseStudies 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
- Model description
- This is a single arm trial where all patients receive the same medication in one eye. This study drug is already FDA approved and this is to get further detail of performance of the medication.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502378
- Sponsor's protocol ID
- Study009655
- Other IDs
- RTI #25-RX23
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We are not a pharmacy distribution company, the information being collected is for medical science to improve patient care options.
Publications
Khalid M, Zahid E, Shaheer M. "Acoltremon: a novel advancement in dry eye disease management". Ann Med Surg (Lond). 2025 Oct 17;87(12):9121-9122. doi: 10.1097/MS9.0000000000004126. eCollection 2025 Dec. No abstract available.
PubMed 41377326Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2026 May;133(5):563-574. doi: 10.1016/j.ophtha.2025.09.018. Epub 2025 Sep 30.
PubMed 41038456Lee A. Acoltremon: First Approval. Drugs. 2025 Oct;85(10):1307-1310. doi: 10.1007/s40265-025-02218-5. Epub 2025 Jul 30.
PubMed 40736647Zhou Y, Zhang W, Sun F. Acoltremon: The first TRPM8 agonist approved for the treatment of dry eye disease. Drug Discov Ther. 2025 Jul 4;19(3):210-211. doi: 10.5582/ddt.2025.01048. Epub 2025 Jun 27.
PubMed 40571589Methods of Reducing Corneal Endothelial Cell Loss U.S. Patent Application, PCT/US2014/066551, filed November 20, 2014 Developed novel methodology to assess decreased nerve density in patients at risk for endothelial cell loss and preventing endothelial cell loss through neuropeptide based therapies.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
- ClinicalTrials.gov ID
- NCT07502378
- Acronym / sponsor ID
- Study009655
- Keywords
- Ocular Surface Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 31 Mar 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.
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
Detailed description
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production in subjects with stage I neurotrophic keratopathy (NK). The study drug, Acoltremon, is formulated to help increase tear production. Since the tissue breakdown of the cornea is causing NK, it is thought that this study treatment may help participants with this disease by enhancing wound healing, repair and regeneration through improving nerve function of the cornea.
Participants will be followed for 8 weeks, evaluating unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1), their mean change in Best Corrected distance visual acuity (ETDRS standards) from day 1 to week 8, and change in central corneal staining from baseline to week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm trial where all patients receive the same medication in one eye. This study drug is already FDA approved and this is to get further detail of performance of the medication.
| Arm | Type | Receives |
|---|---|---|
| Acoltremon 0.003% Ophthalmic Solution | Other | Drug: Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period., Other: Alternative would be patient exiting the trial and starting on tears or other standard of care.Open Label treatment of Acoltremon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal sensation (Cochet-Bonnet less than 4cm in the central cornea)
- Baseline unanesthetized Schirmer's test ≤ 10 mm
- Females of childbearing potential must have a negative pregnancy test.
- Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200).
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 8 days prior to the starting date and artificial tears 2 hours prior to the first study visit and remain off for the duration of the study.
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 |
|---|---|---|
| Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.This is an FDA approved drug. The participants will be educated on the potential instillation site sensation that may occur as reported from the Pivotal Trials and that the sensation may differ between eyes due to the Neurotrophic Keratopathy. Qualified eyes must meet the inclusion and exclusion criteria. If both eyes qualify, then the one with the worst vision will be the study eye. If both eyes have equal visual acuity then the right eye will be the study eye. | Drug | Acoltremon 0.003% Ophthalmic Solution |
| Alternative would be patient exiting the trial and starting on tears or other standard of care.This is an open label trial. If the patient does not do well on Acoltremon Ophthalmic Solution, then the participant will be removed from trial and put on standard of care treatment, other than Acoltremon. | Other | Acoltremon 0.003% Ophthalmic Solution |
Primary outcome
Unanesthetized Schirmer Test
Time frame: 8 weeks
Mean change in unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1)
1 secondary outcome
Unanesthetized Schirmer test
Time frame: 1 Day
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 12 Aug 2026.
- Background: PubMed 41377326Khalid M, Zahid E, Shaheer M. "Acoltremon: a novel advancement in dry eye disease management". Ann Med Surg (Lond). 2025 Oct 17;87(12):9121-9122. doi: 10.1097/MS9.0000000000004126. eCollection 2025 Dec. No abstract available.
- Background: PubMed 41038456Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2026 May;133(5):563-574. doi: 10.1016/j.ophtha.2025.09.018. Epub 2025 Sep 30.
- Background: PubMed 40736647Lee A. Acoltremon: First Approval. Drugs. 2025 Oct;85(10):1307-1310. doi: 10.1007/s40265-025-02218-5. Epub 2025 Jul 30.
- Background: PubMed 40571589Zhou Y, Zhang W, Sun F. Acoltremon: The first TRPM8 agonist approved for the treatment of dry eye disease. Drug Discov Ther. 2025 Jul 4;19(3):210-211. doi: 10.5582/ddt.2025.01048. Epub 2025 Jun 27.
- BackgroundMethods of Reducing Corneal Endothelial Cell Loss U.S. Patent Application, PCT/US2014/066551, filed November 20, 2014 Developed novel methodology to assess decreased nerve density in patients at risk for endothelial cell loss and preventing endothelial cell loss through neuropeptide based therapies.
- Individual participant dataSharing planned: No. We are 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
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 Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. in people with Ocular Surface Disease and Neurotrophic Keratopathy Stage 1, 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 4 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: looking for participants now, as of the sponsor's last update on 12 Aug 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 Pedram Hamrah, MD (813-974-0948, phamrah@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unanesthetized Schirmer Test (time frame: 8 weeks). 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 NCT07502378, which also lists 5 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 12 Aug 2026.