Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification

EMS

Status and phase

Completed

Phase 2

Conditions

Cataract

Ocular Inflammation

Treatments

Drug: Vigadexa®

Drug: SATURNO II association

Study type

Interventional

Funder types

Industry

Identifiers

EMS0118-SATURNO II

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification

Enrollment

118 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants of both sexes, aged 18 years or more;
Participants presenting the diagnosis of cataract with indication for surgery by the phacoemulsification procedure;
Participants who undergo surgery in only 1 eye at a time;
Participants with intraocular pressure (IOP) ≤ 20 mmHg;
Signed consent.

Exclusion criteria

Used non-steroidal anti-inflammatory drugs or topical steroids or systemic inhalers within 21 days prior to randomization of the clinical trial;
Performing the surgery for the second time, to correct the previous procedure or to change the lens;
Decompensated glaucoma or ocular hypertension with IOP above 21 mmHg;
Active ocular infectious diseases;
History hypersensitivity to the active ingredients used in the study;
Pregnancy or risk of pregnancy and lactating patients;
History alcohol abuse or illicit drug use;
Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
Participation in clinical trial in the year prior to this study.