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

Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for the Management of Inflammation and Pain After Phacoemulsification Compared to Prednisolone Acetate 1%.

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.

The study subjects will be recruited from various research centers in western and central Mexico.

Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes.

The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days.

The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico.

The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed.

To verify the integrity, veracity and reliability of the data entered into the e-CRF, the monitors of each center will check the information uploaded to the portal with that reported in the source document of the principal investigator (PI), such as clinical notes, clinical history and documents. and formats attached to the research protocol, physical case report format, as well as those provided by the sponsor to the PI (subject's diary and quality and satisfaction survey).

The e-CRF used for this clinical study is provided by an internationally certified provider with the highest quality standards, protection of information under current regulations and confidentiality guarantee. The information that the PIs enter into the e-CRF is collated and verified by the clinical monitors and by the service provider's personnel, later reviewed and approved by the medical ophthalmologist researcher and by the Clinical Security Pharmacologist, who authorize the monitored data of clinical information and safety of the study molecule, respectively.

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.