PRO-232 in Patients Subjected to Cataract Surgery

Recruiting Phase 3 Interventional Study
Cataract Extraction
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
134 (estimated)
Sponsor
Laboratorios Sophia S.A de C.V. · Industry
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About This Trial

The main objective of this study is to evaluate the efficacy and safety of the PRO-232 formulation manufactured by Laboratorios Sophia S.A. de C.V. on the ocular surface of postoperative cataract patients versus a concomitant administration of ophthalmic moxifloxacin and dexamethasone.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * To have the ability to voluntarily grant their signed informed consent (FCI). * Being able and willing to comply with scheduled visits in the treatment plan and other study procedures. * Being 18 years of age or older. * Male or female. * Women within childbearing age who do n…
Contacts

Oscar Olvera-Montaño, MD

3330004200

oscar.olvera@sophia.com.mx

CONTACT

Alejandra Sánchez-Ríos, MD

3330004200

alejandra.sanchez@sophia.com.mx

CONTACT