CataractPhase 4NCT04631315

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

A Phase 4 study testing Difluprednate Ophthalmic Emulsion 0.05% and Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution in people with Cataract, run by Laboratorios Poen at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cataract
What is being tested?: Difluprednate Ophthalmic Emulsion 0.05% and Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 255 participants
Where: 1 siteArgentina
Study dates: 24 Mar 2019to 21 Jul 2020
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Laboratorios Poen
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1407BDR

Other trials in Argentina

About this study

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.

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
Being tested: Difluprednate Ophthalmic Emulsion 0.05%, Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Difluprednate Ophthalmic Emulsion 0.05%Drug
Also called Tolf®
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.
Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solutionDrug
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.

Study groups in NCT04631315
Study group	Role	What they receive
Intervention	Experimental	Difluprednate Ophthalmic Emulsion 0.05% Receives: Drug: Difluprednate Ophthalmic Emulsion 0.05%
Comparator	Active comparator	Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension Receives: Drug: Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to visit 3 (96 hours from surgery)

Secondary outcomes (7)

Retinal Thickness
Retinal Thickness measured by Optical Coherence Tomography (mm)
Measured: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
Corneal endothelial cell count
Corneal endothelial cell count measured by specular microscope (cells/mm2)
Measured: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Visual acuity
Visual acuity measured by visual acuity standardized chart (20/20)
Measured: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Flare and cell on anterior chamber
Presence of flare and cells on anterior chamber using slit lamp (biomicroscopy)
Measured: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Intraocular pressure
Intraocular pressure measured by Goldmann tonometer (mmHg)
Measured: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Equal safety profile of both treatments
Report of adverse events of both treatments under study
Measured: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
Corneal Thickness by pachymetry
Corneal Thickness (mm)
Measured: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 201921 Jul 2020

First posted17 Nov 2020
Study start24 Mar 2019
Primary completion24 May 2020
Study completion21 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04631315
Sponsor's protocol ID: DIFLUPRED03
Status last verified: Nov 2020
First submitted: 5 Nov 2020
Last updated: 12 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04631315
Acronym / sponsor ID: DIFLUPRED03
Conditions: Cataract
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 255 participants (actual)
Lead sponsor: Laboratorios PoenIndustry (pharma, biotech, devices)
Study start: 24 Mar 2019 (actual)
Primary completion: 24 May 2020 (actual)
Study completion: 21 Jul 2020 (actual)
First posted: 17 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Drug: Difluprednate Ophthalmic Emulsion 0.05%Difluprednate Ophthalmic Emulsion 0.05%
Comparator	Active comparator	Drug: Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solutionPrednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Difluprednate Ophthalmic Emulsion 0.05%Also: Tolf®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	Intervention
Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution1 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.	Drug	Comparator

Primary outcome

Change from baseline corneal thickness between treatments
Time frame: Baseline to visit 3 (96 hours from surgery)
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.

7 secondary outcomes

Retinal Thickness
Time frame: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
Corneal endothelial cell count
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Visual acuity
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Flare and cell on anterior chamber
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Intraocular pressure
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).
Equal safety profile of both treatments
Time frame: Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)
Corneal Thickness by pachymetry
Time frame: Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
Individual participant dataSharing planned: No

Related trials for Cataract

Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jorge Tosi, M.D. study director

Laboratorios Poen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline corneal thickness between treatments (time frame: Baseline to visit 3 (96 hours from surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.