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Completed

NCT Number: NCT03580473

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

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

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Key information

Conditions

Ocular Inflammation Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allegisa

Campinas, São Paulo, 13.084-791, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SATURNO II association

Drug

opthalmic solution, 4 times a day

Other names: Legrand association

Vigadexa®

Drug

opthalmic solution, 4 times a day

Other names: Moxifloxacin Hydrochloride 5mg/mL + Dexamethasone Disodium Phosphate 1mg/mL

Primary outcomes

  1. Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber

    Time frame: 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 outcomes

  1. Incidence and severity of adverse events recorded during the study

    Time frame: 26 days

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 9, 2018
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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