PRO-232 in Patients Subjected to Cataract Surgery
ConditionCataract Extraction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorios Sophia S.A de C.V.
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Allergy to any of the components of the investigational products or to any of the compounds used during testing.
Surgery on both eyes during the same surgical period.
Not having had surgery within a period of 24 hours before inclusion.
Performing iridectomy, or injury to the pupillary sphincter during phacoemulsification surgery.
Trial design
Treatments tested in this trial
- Moxifloxacin / Dexamethasone Ophthalmic Solution
- Placebo
- Moxifloxacin Hydrochloride, Ophthalmic
- Dexamethasone phosphate
Treatment groups
134 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov