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A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects

NCT04945824 ↗

Phase 0 Terminated 2 enrolled Ocular Therapeutix, Inc.
NaSingle-groupOpen-labelOther

Summary

This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.

Timeline

Start
2021-06-01
Primary completion
2022-11-01
Completion
2022-11-01

Outcome

Outcome not reported

Stopped: “inserter device did not perform as expected”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule — Other

Indications

No indication recorded.