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NCT05031806
Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease
Phase 1 trial testing iNexin™ (0.08% aCT1) in Dry Eye Disease in 30 participants. Completed in 1 December 2021.
1 December 2021
Quick facts
| Lead sponsor | Xequel Bio, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 28 September 2021 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- iNexin™ (0.08% aCT1) — full drug profile →
- iNexin™ (0.4% aCT1) — full drug profile →
- iNexin™ (2.0% aCT1) — full drug profile →
- Vehicle (eye drop formulation without aCT1) — full drug profile →
Conditions studied
- Dry Eye Disease — all drugs for Dry Eye Disease →
Sponsor
Xequel Bio, Inc. — full company profile →
Who can join
18 and older, any sex, with Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Vascular Endothelial Barrier Protection Prevents Atrial Fibrillation by Preserving Cardiac Nanostructure.
Mezache L, Soltisz AM, Johnstone SR, Isakson BE, et al · · 2023 · cited 15× · PMID 38032579 · DOI 10.1016/j.jacep.2023.10.013
Verify or expand the search:
- PubMed search for NCT05031806
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dry Eye Disease
Currently open trials in the same condition.
- NCT06596733 — Vit-A-Vision® Clinical Investigation · NA · recruiting
- NCT07264517 — Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED). · Phase 2 · recruiting
- NCT07025811 — A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment · Phase 4 · recruiting
- NCT04946721 — 2177GCCC:ID'Ing tx Targets and Biomarkers for Ocular Surface Disease in Pt w/ oGVHD · recruiting
- NCT06696625 — Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye · NA · recruiting
Other Xequel Bio, Inc. trials
Trials by the same sponsor.
- NCT04684121 — Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing · Phase 2 · withdrawn
- NCT04331080 — A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Brea · Phase 2, PHASE3 · completed
- NCT02667327 — A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer · Phase 3 · terminated
- NCT04473859 — Study to Evaluate the Safety of FSR Peptide Versus Placebo Following Punch Biopsy · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05031806 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xequel Bio, Inc.
- Last refreshed: 4 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05031806.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing