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

• Status: Completed
• Trial end date: 2019-10-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Difluprednate; Fluprednisolone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• History of uveitis.

• Presence of corneal abrasion or corneal ulceration in the study eye.

• Use of steroids or topical non steroidal anti inflammatory drugs, 24 hours prior to surgery and until the start of instillation of investigational drugs.

• Use of anticoagulants, systemic steroids or immunomodulators in the last two weeks

• Periocular injection of any steroid in the study eye 4 weeks before the start of the instillation of the investigational drugs.

• Use of storage steroids 2 months prior to the start of instillation of investigational drugs.

• Presence or suspicion of keratitis and / or viral, bacterial or fungal conjunctivitis.

• Presence or suspicion of endophthalmitis.

• Presence or suspicion of toxic syndrome of the anterior segment.

• Severe corneal edema that does not allow assessment of the anterior chamber

• Macular diseases.

• Diabetes Mellitus with glycosylated hemoglobin (A1C) ≥ 6.5% (48 mmol / mol) or fasting glucose (no caloric intake by ≥ 8 hours) of ≥ 126 mg / dL (7.0 mmol / L).

• Any disease or condition that requires the use of topical or systemic nonsteroidal anti-inflammatories (NSAIDs) during the time of intervention.

• Any disease or condition that requires the use of steroids other than topical ophthalmic application.

• Subjects with a single eye.

• Any condition or disease that at the discretion of the principal investigator (IP) does not make the subject suitable for the study.

• Known hypersensitivity to the components of the products under investigation.