Drug intelligence / Profile preview

PRO-165

Development stage
Phase 1
Lead developer
Laboratorios Sophia
Administration
Ophthalmic
01

Overview

**PRO-165** is an investigational ophthalmic lubricant gel developed and manufactured by Laboratorios Sophia for ocular-surface lubrication and dry eye syndromes. It was evaluated in a randomized, double-blind Phase I study in healthy subjects versus carbomer ophthalmic gel, with ophthalmic administration of one drop four times daily for 10 days. Archived protocol versions identify conflicting active compositions: an earlier version specifies chondroitin sulfate 0.18% plus sodium hyaluronate 0.2%, whereas a later version specifies sodium hyaluronate 0.2% alone. ([cdn.clinicaltrials.gov](https://cdn.clinicaltrials.gov/large-docs/76/NCT03697876/Prot_000.pdf))

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