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NCT07502378 · ClinicalTrials.gov registry record · Phase 4
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, sponsored by University of South Florida.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT07502378: Recruiting Phase 4 study, sponsored by University of South Florida.
NCT07502378 is a Phase 4 study that is actively recruiting participants, run by University of South Florida. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07502378, a Phase 4 study, is actively recruiting participants, sponsored by University of South Florida.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
Primary Outcome
Mean change in unanesthetized Schirmer test score between 3 minutes post-drop week 8 compared to pre-drop at baseline (day 1)
Interventions
- 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-03-27 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 4 |
What NCT07502378 shows while recruiting
NCT07502378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. is the first listed.
NCT07502378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07502378 about?
NCT07502378 is a clinical study titled "Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency". STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.
What is the current status of trial NCT07502378?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2026-03-27. Estimated completion is 2027-08-31.
What interventions are being tested in trial NCT07502378?
The interventions under investigation include: Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period. (DRUG), Alternative would be patient exiting the trial and starting on tears or other standard of care. (OTHER).
Who is sponsoring clinical trial NCT07502378?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07502378's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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