Neuropathic Corneal PainPhase 3NEPTUNENCT07838506
Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod Ophthalmic Solution in Participants With Neuropathic Corneal Pain (NCP).
A Phase 3 study testing Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks. in people with Neuropathic Corneal Pain, run by Okyo Pharma Ltd at 1 site in United States.
Trial summary
This study is testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Corneal Pain
- What is being tested?
- Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Oct 2027
- Phase
- Phase 3
- 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
- Aged 18 years of age or older.
- Able and willing to provide written informed consent prior to any study-related procedures.
- Presence of symptoms of neuropathic corneal pain for at least 3 months defined as the presence of ocular pain associated or not with ocular symptoms of burning, stinging, light sensitivity or discomfort.
- In at least one eye:
- Ocular pain score of 5 or more on 0-10 Visual Analogue Scale (VAS) AND in the same eye
- In Vivo Confocal Microscopy (IVCM) changes of the subbasal corneal nerve plexus assessed by an Investigator who has received study-specific training.
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- Female participants must be one of the following: a) postmenopausal (defined as no menses for 1 year), b) surgically sterilized, c) practicing abstinence as a lifestyle choice (not as a form of contraception), or d) consistently and correctly using protocol-specified birth control for the duration of the study (e.g., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide; see Appendix 3).
- Female participants who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test at the Screening and Day 1/Baseline visits.
- Best corrected distance visual acuity (BCDVA), in the study eye of at least Snellen >20/200.
- Participants that require topical ophthalmic medications during the study may be included if the medications are not topical ophthalmic blood-derived products, amniotic-membrane derived medications, cenegermin (Oxervate®), topical ophthalmic anti-allergic, anti-inflammatory, immunosuppressive and immunomodulators such as lifitegrast, and the dose has been stable for at least 3 months prior to Screening and is expected to remain stable throughout the study period.
- Ability and willingness to comply with study procedures.
Who cannot join
- Participants who meet any of the following criteria at Visit 1/Screening or Visit 2/Baseline will be excluded from the study.
- Evidence of any active ocular infection (bacterial, viral, fungal or protozoal) in either eye.
- Evidence of any intraocular inflammation defined as anterior chamber flare > 0 and/or cells >0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
- Presence of any other ocular surface condition that may cause ocular pain including confluent punctuate staining, any corneal epithelial defect or ulcer, angle-closure glaucoma or uveitis, in either eye.
- Presence of eyelid abnormalities such as trichiasis and lagophthalmos that can be the primary cause of corneal epithelial damage and ocular pain.
- Evidence of any elevated corneal scars/corneal edema.
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- Any other concomitant medical condition that, in the judgment of the Principal Investigator (PI), might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being.
- Use of topical ophthalmic calcineurin inhibitors such as Cyclosporin A, tacrolimus, pimecrolimus, or cenegermin (Oxervate®) in either eye in the 4 weeks prior to Visit 1/Screening visit.
- History of severe systemic allergic condition or severe ocular allergy.
- Inability to suspend use of intranasal tear secretagogues such as varenicline or device for dry eye at Visit 1/Screening and throughout the study period.
- Inability to suspend prohibited ocular topical medications at Visit 1/Screening.
- Inability to suspend use of blood-derived ocular treatments (e.g., autologous serum tears, platelet-rich plasma, etc.) or amniotic membrane-derived products at Visit 1/Screening visit.
- Inability to continue stable (for at least 3 months) oral medications for NCP without changes during the entire study period.
- No change or less than 50% improvement in ocular pain assessed by VAS score after topical anesthetic challenge.
- History of any ocular surgery within 3 months prior to Visit 1/Screening.
- Any anticipated ocular surgery during the entire study period.
- Inability to suspend use of refractive/therapeutic contact lenses (including scleral lenses), botulinum toxin or electro/magnetic stimulation devices on the eye, face or scalp, during the entire study period.
- Prior use of periocular or ocular botulinum toxin (Botox) within 3 months of Visit 1/Screening.
- Evidence of current drug or alcohol abuse or addiction.
- Participated in or used the investigational agent in another clinical study, within 30 days prior to Visit 1/Screening.
- Known hypersensitivity to any of the components of the study drug, preservative-free artificial tears or procedural medications (e.g., fluorescein, anesthetic drops, etc.).
- Previous participation in a clinical study or extended access program with urcosimod eye drops.
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
Toyos Eye Clinic
Nashville, Tennessee, 37215
Study Coordinator, 615-327-4015, hcheney@toyosclinic.com
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod (Formerly Called OK-101) Ophthalmic Solution in Participants With Neuropathic Corneal Pain (NCP).
This study is testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP).
Read the detailed description
This research study is to evaluate the safety of Urcosimod Ophthalmic Solution and its effect on the quality of life and vision in participants with Neuropathic Corneal Pain (NCP). The purpose of this research study will see if urcosimod can safely and effectively relieve the signs and symptoms of NCP, and whether it causes any side effects.
- Conditions
- Neuropathic Corneal Pain
- Being tested
- Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks., Vehicle Ophthalmic Solution
- Keywords
- NEPTUNE, NCP, Ocular pain, Urcosimod
- Medical subject headings
- Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.Drug
Topical ophthalmic solution, applied as 1 drop QID in affected eye(s)* for the 12-week Treatment Period
Vehicle Ophthalmic SolutionOther
Vehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Urcosimod Ophthalmic Solution | Experimental | • Urcosimod 0.05% - one drop in affected eye(s), four times a day Receives: Drug: Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks. |
| Vehicle ophthalmic solution | Placebo comparator | Vehicle - one drop in affected eye(s), four times a day. Receives: Other: Vehicle Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline at Week 12 in ocular pain assessed by Visual Analogue Scale (0-10) score. (Score of 10 is "worst possible pain".)
Evaluate the efficacy and safety of urcosimod 0.05% as compared to placebo instilled 4 times/day in participants who have a documented ocular history of symptoms of neuropathic corneal pain.
Measured: From baseline (time of randomization) compared to Week 12.
Secondary outcomes (3)
Change from baseline at Week 12 in Quality-of-Life score.
Evaluate improvement in quality-of-life as measured by the Ocular Pain Assessment Survey.
Measured: Baseline visit compared to Week 12.
Change from baseline at Weeks 4, 8, and 16 in ocular pain assessed by Visual Analogue Scale (0-10) score. (Score of 10 is "worst possible pain".)
Evaluate improvement in ocular pain assessed by Visual Analogue Scale score.
Measured: Baseline visit compared to Weeks 4, 8 and 16.
Change from baseline at Week 2 in ocular pain assessed by Visual Analogue Scale (0-10) score in the participant diary. (Score of 10 is "worst possible pain".)
Evaluate improvement in ocular pain assessed by Visual Analogue Scale (0-10) score.
Measured: Baseline visit compared to Week 2 of treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Corneal PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3 study is designed to evaluate the safety and efficacy of urcosimod 0.05% eye drops compared to vehicle as the placebo control when dosed QID for 12 weeks in participants with neuropathic corneal pain. Study includes 6 planned site visits (Visit 1/Screening \[Day -7 to Day 1 prior to Baseline\], Visit 2/Baseline/Day 1, Visit 3/Week 4, Visit 4/Week 8, Visit 5/Week 12/End of Treatment Period, Visit 6/Week 16/End of Study Visit. If eligibility criteria are met at Visit 2/Baseline, participants will be randomized, Investigational Medicinal Product (IMP) dispensed and self-administration will start at Visit 2/Day 1 and continue for 12 weeks (through Visit 5/End of Treatment visit). After completion of treatment, participants will enter a 4-week follow-up period for post-treatment evaluation and safety follow-up with 1 clinic visit at Week 16/End of Study (Visit 6)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okyo Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flavio Mantelli, MD, PhD, Study director, Okyo Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838506
- Sponsor's protocol ID
- OK-101-NCP-001-26
- Acronym
- NEPTUNE
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study Assessing the Safety and Efficacy of Urcosimod (Formerly Called OK-101) Ophthalmic Solution in Participants With Neuropathic Corneal Pain (NCP).
- ClinicalTrials.gov ID
- NCT07838506
- Acronym / sponsor ID
- NEPTUNE / OK-101-NCP-001-26
- Conditions
- Neuropathic Corneal Pain
- Keywords
- NEPTUNE, NCP, Ocular pain, Urcosimod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Okyo Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 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 testing a new investigational study drug called Urcosimod Ophthalmic Solution for the treatment of Neuropathic Corneal Pain (NCP).
Detailed description
This research study is to evaluate the safety of Urcosimod Ophthalmic Solution and its effect on the quality of life and vision in participants with Neuropathic Corneal Pain (NCP). The purpose of this research study will see if urcosimod can safely and effectively relieve the signs and symptoms of NCP, and whether it causes any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase 3 study is designed to evaluate the safety and efficacy of urcosimod 0.05% eye drops compared to vehicle as the placebo control when dosed QID for 12 weeks in participants with neuropathic corneal pain. Study includes 6 planned site visits (Visit 1/Screening [Day -7 to Day 1 prior to Baseline], Visit 2/Baseline/Day 1, Visit 3/Week 4, Visit 4/Week 8, Visit 5/Week 12/End of Treatment Period, Visit 6/Week 16/End of Study Visit. If eligibility criteria are met at Visit 2/Baseline, participants will be randomized, Investigational Medicinal Product (IMP) dispensed and self-administration will start at Visit 2/Day 1 and continue for 12 weeks (through Visit 5/End of Treatment visit). After completion of treatment, participants will enter a 4-week follow-up period for post-treatment evaluation and safety follow-up with 1 clinic visit at Week 16/End of Study (Visit 6)
| Arm | Type | Receives |
|---|---|---|
| Urcosimod Ophthalmic Solution | Experimental | Drug: Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.• Urcosimod 0.05% - one drop in affected eye(s), four times a day |
| Vehicle ophthalmic solution | Placebo comparator | Other: Vehicle Ophthalmic SolutionVehicle - one drop in affected eye(s), four times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 years of age or older.
- Able and willing to provide written informed consent prior to any study-related procedures.
- Presence of symptoms of neuropathic corneal pain for at least 3 months defined as the presence of ocular pain associated or not with ocular symptoms of burning, stinging, light sensitivity or discomfort.
- In at least one eye:
- Female participants must be one of the following: a) postmenopausal (defined as no menses for 1 year), b) surgically sterilized, c) practicing abstinence as a lifestyle choice (not as a form of contraception), or d) consistently and correctly using protocol-specified birth control for the duration of the study (e.g., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide; see Appendix 3).
Key exclusion criteria (22 listed)
- Participants who meet any of the following criteria at Visit 1/Screening or Visit 2/Baseline will be excluded from the study.
- Evidence of any active ocular infection (bacterial, viral, fungal or protozoal) in either eye.
- Evidence of any intraocular inflammation defined as anterior chamber flare > 0 and/or cells >0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.
- Presence of any other ocular surface condition that may cause ocular pain including confluent punctuate staining, any corneal epithelial defect or ulcer, angle-closure glaucoma or uveitis, in either eye.
- Presence of eyelid abnormalities such as trichiasis and lagophthalmos that can be the primary cause of corneal epithelial damage and ocular pain.
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 |
|---|---|---|
| Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks.Topical ophthalmic solution, applied as 1 drop QID in affected eye(s)* for the 12-week Treatment Period | Drug | Urcosimod Ophthalmic Solution |
| Vehicle Ophthalmic SolutionVehicle solution of the study drug (without active ingredient); preservative-free topical ophthalmic solution supplied in unit-dose ampoules; administered QID for 12-weeks. | Other | Vehicle ophthalmic solution |
Primary outcome
The change from baseline at Week 12 in ocular pain assessed by Visual Analogue Scale (0-10) score. (Score of 10 is "worst possible pain".)
Time frame: From baseline (time of randomization) compared to Week 12.
Evaluate the efficacy and safety of urcosimod 0.05% as compared to placebo instilled 4 times/day in participants who have a documented ocular history of symptoms of neuropathic corneal pain.
3 secondary outcomes
Change from baseline at Week 12 in Quality-of-Life score.
Time frame: Baseline visit compared to Week 12.
Change from baseline at Weeks 4, 8, and 16 in ocular pain assessed by Visual Analogue Scale (0-10) score. (Score of 10 is "worst possible pain".)
Time frame: Baseline visit compared to Weeks 4, 8 and 16.
Change from baseline at Week 2 in ocular pain assessed by Visual Analogue Scale (0-10) score in the participant diary. (Score of 10 is "worst possible pain".)
Time frame: Baseline visit compared to Week 2 of treatment period.
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Flavio Mantelli, MD, PhD study director
Okyo Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Urcosimod ophthalmic solution is a preservative-free topical ophthalmic product; supplied in unit dose ampoules; administered QID for 12-weeks. in people with Neuropathic Corneal Pain, run by Okyo Pharma Ltd 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 11 inclusion and 22 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 29 Sep 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline at Week 12 in ocular pain assessed by Visual Analogue Scale (0-10) score. (Score of 10 is "worst possible pain".) (time frame: From baseline (time of randomization) compared to Week 12.). 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 29 Sep 2026.