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

NCT03693989 | Completed Phase 3 Results DMC

• 1 other identifier: SOPH145-0716 / III
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

corticosteroid; anti-inflammatory steroid; phacoemulsification

Outcome Measures

Primary Outcomes (2)

• Visual Ability (VA)

  The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The result of the Snellen fraction will be transformed to its decimal equivalent in LogMAR, ex. 20/20= 1.0, 20/25=0.8, 20/40= 0.5, 20/200= 1.0, etc. The subjects will be averaged by group.

  day 28 at the final visit

• Adverse Events

  The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of cases with adverse events will be reported per study arm

  day 28 at the final visit

Secondary Outcomes (7)

• Cellularity in the Anterior Chamber

  day 28 at the final visit

• Clinical Corneal Edema

  day 28 at the final visit

• Flare

  day 28 at the final visit

• Central Thickness of the Retina

  day 28 at the final visit

• Conjunctival Hyperemia

  day 28 at the final visit

Study Arms (2)

PRO-145.

EXPERIMENTAL

Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.

Drug: Difluprednate 0.05%

Prednefrin

ACTIVE COMPARATOR

Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V.

Drug: Prednefrin

Interventions

Difluprednate 0.05% DRUG

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.

Also known as: PRO-145

PRO-145.

Prednefrin DRUG

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

Also known as: Difluprednate

Prednefrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Age ≥ 18 years.
• Both sexes.
• Postoperative cataract surgery by phacoemulsification. o That they have met the criteria for phacoemulsification and a classification of the lens opacity classification system (LOCS) III cataract of Opalescence of the nucleus (NO) ≥2 and Kernel color (NC) ≥2.

You may not qualify if:

• Pregnant women, lactating or planning to get pregnant.
• Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
• Participation in another clinical research study ≤ 30 days before the baseline visit.
• Have previously participated in this same study with the contralateral eye.
• That they can not comply with their attendance at appointments or with all the requirements of the protocol.
• Medical and therapeutic criteria.
• Surgery in both eyes in the same surgical shift.
• Time\> 24 hours after having surgery.
• Intraocular lens placement outside the bag.
• Presentation of rupture of the posterior capsule, with or without the presence of vitreous.
• Carrying out an iridectomy, or lesion of the pupillary sphincter during phacoemulsification surgery.
• Scheduled for surgical intervention in the contralateral eye during the study period.
• History of glaucoma or ocular hypertension.
• History of increased Intraocular pressure (IOP) with the use of steroids.
• Intraocular pressure (IOP) ≥24.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (5)

Catarata y Glaucoma de Occidente

Guadalajara, Jalisco, 44160, Mexico

Location

Novam y Vita

Guadalajara, Jalisco, 44620, Mexico

Location

Vision Cirugia Ambulatoria

Monterrey, Nuevo León, 64710, Mexico

Location

Hospital de la luz

Mexico City, 06030, Mexico

Location

Fundación de asistencia privada Conde de Valenciana

Mexico City, 06800, Mexico

Location

Related Publications (1)

• Palacio-Pastrana C, Chavez-Mondragon E, Soto-Gomez A, Suarez-Velasco R, Montes-Salcedo M, Fernandez de Ortega L, Nasser-Nasser L, Baiza-Duran L, Olvera-Montano O, Munoz-Villegas P. Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial. Clin Ophthalmol. 2020 Jun 12;14:1581-1589. doi: 10.2147/OPTH.S254705. eCollection 2020.

  PMID: 32606573 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

prednefrin; difluprednate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Ricardo Llamas (clinical safety pharmacologist)
• Organization: Laboratorios Sophia

ricardo.llamas@sophia.com.mx

+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding and masking The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner in the case of a partial and final analysis. The masking will be carried out using boxes in the identical primary packaging in the two groups and re-labeling the bottles of both interventions. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the assignment number.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, controlled, parallel group, multicentre, randomized

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: October 4, 2018
• Primary Completion: August 7, 2019
• Study Completion: October 22, 2019
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Locations

ME (5)