Cataract Removal Clinical Trials

Clinical trials related to Cataract Removal Procedure

Phase III Clinical Study, to Evaluate the Efficacy and Safety of PRO-232 Ophthalmic Solution on the Ocular Surface of Patients Postoperative to Cataract Surgery by Phacoemulsification.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 not have a history of bilateral tubaric obstruction, hysterectomy, or bilateral oophorectomy should ensure continued use (initiated ≥ 30 days prior to signing the ICF) of a hormonal contraceptive method or intrauterine device (IUD) during the study period.

• Having a postoperative diagnosis (unilateral, single eye) of cataract extraction by phacoemulsification with uncomplicated intraocular lens (IOL) placement\*\* on the day prior to inclusion.

• Having an intraocular pressure ≥ 8 and ≤ 21 mmHg.

⁃ A complicated cataract surgery will be defined by study, as any procedure where the planned surgical technique has been modified or the use of vitrectomy has been required, an IOL has not been placed, a different IOL from the originally planned model has been placed or an IOL has been placed outside the capsular bag, remains of the lens have been left inside the eye, there was rupture of the posterior capsule with or without the presence of vitreous, or detachment of Descemet's membrane occured, there was disinsertion of the capsular pouch, or there was trauma to the iris or ciliary body during the surgical procedure. In the event of any other situation that could be considered a complication and that is not reflected in this list, the inclusion of said patient will be at the discretion of the researcher.

Locations
Other Locations
Mexico
RGH Integra
RECRUITING
Puebla City
Retina Center
RECRUITING
Tijuana
Contact Information
Primary
Oscar Olvera-Montaño, MD
oscar.olvera@sophia.com.mx
3330004200
Backup
Alejandra Sánchez-Ríos, MD
alejandra.sanchez@sophia.com.mx
3330004200
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 134
Treatments
Experimental: PRO-232
Two eyedroppers: one for PRO-232 and another for Placebo. Both will be administrated as follows: 1 drop four times a day (QID) with a minimum of four hours between applications, in the study eye for 14 days; with the exception of day 1 (the same day of the baseline visit), where a reduction in the interval between applications to a minimum of 3 hours per day will be allowed. A period of minimum 5 minutes between eyedropper administration will be required.
Active_comparator: Moxifloxacin / Dexamethasone
Two eyedroppers: one for moxifloxacin and another for dexamethasone. Both will be administrated as follows: 1 drop four times a day (QID) with a minimum of four hours between applications, in the study eye for 14 days; with the exception of day 1 (the same day of the baseline visit), where a reduction in the interval between applications to a minimum of 3 hours per day will be allowed. A period of minimum 5 minutes between eyedropper administration will be required.
Related Therapeutic Areas
Sponsors
Leads: Laboratorios Sophia S.A de C.V.

This content was sourced from clinicaltrials.gov

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