Trial intelligence / Profile preview

NE.DE.F. Study: Nepafenac/Dexamethasone FDC vs Monotherapies After Cataract Surgery

2025-523367-38-00Phase 3Authorised

Sponsor
Medivis
Start
Feb 2026
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Small Molecules
Countries
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Overview

Phase 3, randomised, single-blind trial in Postoperative ocular inflammation, Conjunctival Erythema and Ocular pain is not a disease; it is a symptom. The canonical disease entity most closely related to persistent, unexplained ocular pain is "ocular neuropathic pain" or "neuropathic ocular pain" comparing Nepafenac + dexamethasone fixed-dose combination, Nepafenac monotherapy and Dexamethasone monotherapy (3 arms). Primary endpoint: Time to resolution of postoperative anterior chamber inflammation. Planned start Feb 2026; status: authorised.

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Drugs

nepafenacdexamethasone
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Conditions

Postoperative ocular inflammationConjunctival ErythemaOcular pain is not a disease; it is a symptom. The canonical disease entity most closely related to persistent, unexplained ocular pain is "ocular neuropathic pain" or "neuropathic ocular pain".

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