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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Dexamethasone; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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.