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

Cataract Clinical Trial

Official title:

Phase II, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580473
• Other study ID #: EMS0118-SATURNO II
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 1, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Inflammation
• Ocular Inflammation

Intervention

Drug:
• SATURNO II association
opthalmic solution, 4 times a day
• Vigadexa®
opthalmic solution, 4 times a day

Locations

Country	Name	City	State
Brazil	Allegisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber	The inflammation will be evaluated though the presence of cells in the anterior chamber. For this, the number of cells per high-power field in the anterior chamber was counted and recorded on a scale where 0 indicates = 5 cells, 1 = 5 to 10 cells, 2 = 11 to 20 cells, 3 = 21 to 50 cells, and 4 corresponds to = 50 cells.	16 days
Secondary	Incidence and severity of adverse events recorded during the study		26 days