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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

Argentina

Study Type

Interventional

Intervention

Difluprednate Ophthalmic Emulsion 0.05%

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

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Laboratorios Poen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Comparator

Arm Description

Difluprednate Ophthalmic Emulsion 0.05%

Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension

Outcomes

Primary Outcome Measures

Change from baseline corneal thickness between treatments

Demonstrate that 0.05% difluprednate ophthalmic nanoemulsion administered 1 drop, 2 times a day, beginning the day before cataract surgery and continuing for the first 14 postoperative days and then 1 drop, once a day for the next 14 days, it does not present an anti-inflammatory efficacy lower than treatment with prednisolone acetate 1% + phenylephrine hydrochloride 0.12% ophthalmic suspension administered 1 drop, 4 times a day starting the day before surgery and continuing during the first 14 post-surgical days and 1 drop , 2 times a day for the next 14 days, for the treatment of postsurgical inflammation, in patients operated on for N2 and N3 cataracts. Difluprednate 0.05% ophthalmic nanoemulsion will not be clinically inferior than Prednisolone acetate 1% + 0.12% phenylephrine hydrochloride ophthalmic suspension, if the difference in corneal thickness obtained with OCT between the baseline day and the post-surgical day it does not differ beyond 17 µm between treatments.

Secondary Outcome Measures

Retinal Thickness

Retinal Thickness measured by Optical Coherence Tomography (mm)

Corneal endothelial cell count

Corneal endothelial cell count measured by specular microscope (cells/mm2)

Visual acuity

Visual acuity measured by visual acuity standardized chart (20/20)

Flare and cell on anterior chamber

Presence of flare and cells on anterior chamber using slit lamp (biomicroscopy)

Intraocular pressure

Intraocular pressure measured by Goldmann tonometer (mmHg)

Equal safety profile of both treatments

Report of adverse events of both treatments under study

Corneal Thickness by pachymetry

Corneal Thickness (mm)

Full Information

NCT ID

NCT04631315

First Posted

November 5, 2020

Last Updated

May 11, 2023

Sponsor

Laboratorios Poen

1. Study Identification

Unique Protocol Identification Number

NCT04631315

Brief Title

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

Official Title

Efficacy and Safety of Difluprednate Ophthalmic Emulsion vs. a Fixed-Combination of Prednisolone Acetate - Phenylephrine Ophthalmic Suspension on Post-operative Inflammation Following Cataract Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

March 24, 2019 (Actual)

Primary Completion Date

May 24, 2020 (Actual)

Study Completion Date

July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Poen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

255 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Difluprednate Ophthalmic Emulsion 0.05%

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension

Intervention Type

Drug

Intervention Name(s)

Difluprednate Ophthalmic Emulsion 0.05%

Other Intervention Name(s)

Tolf®

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline corneal thickness between treatments

Description

Time Frame

Baseline to visit 3 (96 hours from surgery)

Secondary Outcome Measure Information:

Title

Retinal Thickness

Description

Retinal Thickness measured by Optical Coherence Tomography (mm)

Time Frame

Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)

Title

Corneal endothelial cell count

Description

Corneal endothelial cell count measured by specular microscope (cells/mm2)

Time Frame

Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

Title

Visual acuity

Description

Visual acuity measured by visual acuity standardized chart (20/20)

Time Frame

Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

Title

Flare and cell on anterior chamber

Description

Presence of flare and cells on anterior chamber using slit lamp (biomicroscopy)

Time Frame

Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

Title

Intraocular pressure

Description

Intraocular pressure measured by Goldmann tonometer (mmHg)

Time Frame

Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

Title

Equal safety profile of both treatments

Description

Report of adverse events of both treatments under study

Time Frame

Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)

Title

Corneal Thickness by pachymetry

Description

Corneal Thickness (mm)

Time Frame

Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Tosi, M.D.

Organizational Affiliation

Laboratorios Poen

Official's Role

Study Director

Facility Information:

Facility Name

Laboratorios Poen

City

Ciudad Autonoma de Buenos Aire

State/Province

Ciudad Autonoma De Buenos Aires

ZIP/Postal Code

C1407BDR

Country

Argentina

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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