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

NCT ID: NCT04631315

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-24
• Study Completion Date: 2020-07-21

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Difluprednate Ophthalmic Emulsion 0.05%

Group Type: EXPERIMENTAL

Difluprednate Ophthalmic Emulsion 0.05%

Intervention Type: DRUG

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.

Comparator

Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Tolf®

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes between 45 and 65 years old (women who are not fertile) who undergo cataract surgery N2 and N3, defined according to BCN10, Decimal classification of cataracts.
• That the surgical technique is ultrasonic phacoemulsification.
• Patients who have an initial corneal thickness between 500 and 570 µm inclusive.
• Patients with initial intraocular pressure between 12 and 18 mm Hg inclusive.
• Patients with an endothelial cell count greater than 1000 cells / mm2

Exclusion Criteria

• Patients who use eye medication, except eye lubricant.
• Patients who before surgery have not been able to dilate their pupil more than 5 mm
• Patients who have been treated with corticosteroids or systemic anti-inflammatory drugs for 2 weeks prior to enrollment
• Patients who have received periocular corticosteroid injections in the study eye within the previous 4 weeks or used depot corticosteroids within 2 months prior to enrollment
• Patients who have received a topical ocular corticosteroid or non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to enrollment
• History of glaucoma or ocular hypertension in the study eye, history or presence of endogenous uveitis, or corneal abrasion or ulceration
• Patients with a diagnosis or suspicion of keratoconjunctival disease caused by viruses, bacteria, or fungi
• Patients which presents an allergy to the drug to be tested or to any similar drug such as other corticosteroids
• History of increased intraocular pressure due to the use of corticosteroids
• Patients with pathological macular features
• Diabetics
• Breastfeeding women
• Patients with rheumatoid arthritis.
• Patients treated with Amiodarone

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Poen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Tosi, M.D.

Role: STUDY_DIRECTOR

Laboratorios Poen

Locations

Laboratorios Poen

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

Countries

Argentina

Other Identifiers

DIFLUPRED03

Identifier Type: -

Identifier Source: org_study_id