CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
AURN001 +2 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06041256
NCT06041256Phase 2Completed
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CLARA: A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel-Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)

Aurion Biotech·interventional·Posted Sep 18, 2023·Updated Dec 17, 2025

In Brief

A Phase 2 clinical trial evaluating AURN001, Corneal Endothelial Cells, and 1 other intervention for Corneal Edema and Corneal Endothelial Dysfunction. Completed, enrolled 97 participants across 20 sites in 2 countries.

Detailed Summary

The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorneal Edema, Corneal Endothelial Dysfunction
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedSep 18, 2023
Enrollment StartOct 18, 2023
Primary CompletionOct 25, 2024
Study CompletionApr 15, 2025
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 2.8 years ago

Interventions

AURN001combination

Corneal Endothelial Cells and Y27632

Corneal Endothelial Cellsbiological

Corneal Endothelial Cells

Y27632drug

Y27632