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Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.

NCT04631315 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2023-05-12

No results posted yet for this study

Summary

This controlled, randomized, double blind, multicenter study will be carried out to demonstrate that the topical ophthalmic nanoemulsion of difluprednate 0.05% (Tolf®, Poen Laboratories), has a high anti-inflammatory efficacy, which would allow it to be administered after cataract surgery 1 drop, twice a day , starting the day before surgery and continuing for 14 days and 1 drop, once a day for the following 2 weeks, achieving an adequate anti-inflammatory activity, with the benefit of reducing the toxicity on the ocular surface, improving the dosage and adherence to treatment.

The follow-up time will be 28 days and the outcome measures will be evaluated in a baseline (time 0), on day 1, on day 4 and on day 28 after surgery. The active control will be prednisolone acetate 1% + phenylephrine hydrochloride 0.12% topical ophthalmic suspension (Prednefrin® Forte, Allergan Argentina) given 1 drop, 4 times a days and 1 drop, twice a day for the next 2 weeks. Corneal thickness, central macula thickness, endothelial cell count, intraocular pressure, visual acuity, anterior chamber clearance and lacrimal film recovery will be evaluated.

Conditions

  • Cataract

Interventions

DRUG

Difluprednate Ophthalmic Emulsion 0.05%

1 drop, 2 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, once a day for the next 2 weeks.

DRUG

Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution

1 drop, 4 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, twice a day for the next 2 weeks.

Sponsors & Collaborators

  • Laboratorios Poen

    lead INDUSTRY

Principal Investigators

  • Jorge Tosi, M.D. · Laboratorios Poen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-24
Primary Completion
2020-05-24
Completion
2020-07-21
FDA Drug
Yes

Countries

  • Argentina

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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 NCT04631315 on ClinicalTrials.gov