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NCT05031806 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease
A Phase 1 study, sponsored by Xequel Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT05031806: Completed Phase 1 study, sponsored by Xequel Bio.
NCT05031806 is a Phase 1 study that has completed, run by Xequel Bio. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05031806, a Phase 1 study, has completed, sponsored by Xequel Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of iNexin™ The secondary objective is to compare the efficacy of iNexin™ to Vehicle for the treatment of the signs and symptoms associated with dry eye disease.
Primary Outcome
Assessed using: Visual Acuity (VA) (ETDRS), Slit-lamp biomicroscopy, Adverse Event Query, Dilated Fundoscopy Interocular Pressure
Interventions
- DRUG iNexin™ (0.08% aCT1)
- DRUG iNexin™ (0.4% aCT1)
- DRUG iNexin™ (2.0% aCT1)
- DRUG Vehicle (eye drop formulation without aCT1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2021-12-01 |
| Phase | Phase 1 |
What the finished NCT05031806 record still lists
NCT05031806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which iNexin™ (0.08% aCT1) is the first listed.
NCT05031806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05031806 about?
NCT05031806 is a clinical study titled "Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease". The primary objective of this study is to evaluate the safety and tolerability of iNexin™ The secondary objective is to compare the efficacy of iNexin™ to Vehicle for the treatment of the signs and symptoms associated with dry eye disease.
What is the current status of trial NCT05031806?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-09-28. Estimated completion is 2021-12-01.
What interventions are being tested in trial NCT05031806?
The interventions under investigation include: iNexin™ (0.08% aCT1) (DRUG), iNexin™ (0.4% aCT1) (DRUG), iNexin™ (2.0% aCT1) (DRUG), Vehicle (eye drop formulation without aCT1) (DRUG).
Who is sponsoring clinical trial NCT05031806?
This trial is sponsored by Xequel Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05031806's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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