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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03580473

Enrollment

118

Registered

2018-07-09

Start date

2020-02-27

Completion date

2022-03-01

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Ocular Inflammation

Brief summary

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

Interventions

DRUGSATURNO II association

opthalmic solution, 4 times a day

DRUGVigadexa®

opthalmic solution, 4 times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber	16 days	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.

Secondary

Measure	Time frame
Incidence and severity of adverse events recorded during the study	26 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026