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Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification

NCT03693989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2019-12-02

Study results available
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Summary

objective: To evaluate the efficacy of the ophthalmic emulsion PRO-145 in the treatment of inflammation and pain after phacoemulsification.

Hypothesis:

The use of the ophthalmic emulsion PRO-145 is effective in decreasing the inflammatory response evaluated by means of cellularity in the anterior chamber, after phacoemulsification.

Methodology:

Phase III clinical trial, double-blind, controlled, parallel group, multicentre, randomized.

Number of patients:

178 subjects divided into 2 groups (89 subjects per group), who will provide an eye for the evaluation of efficacy.

Diagnosis and main inclusion criteria:

Diagnosis: Postoperative phacoemulsification and foldable intraocular lens placement in a bag.

Conditions

  • Cataract

Interventions

DRUG

Difluprednate 0.05%

Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.

DRUG

Prednefrin

1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator. \- Route of administration: topical ophthalmic

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Leopoldo Baiza Durán, MD · Laboratorios Sophia S.A de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2019-08-07
Completion
2019-10-22

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03693989 on ClinicalTrials.gov