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%.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 178
- Locations
- 5
- Primary Endpoint
- Visual Ability (VA)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) ≥
- •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.
Arms & Interventions
PRO-145.
Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
Intervention: Difluprednate 0.05% (Drug)
Prednefrin
Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V.
Intervention: Prednefrin (Drug)
Outcomes
Primary Outcomes
Visual Ability (VA)
Time Frame: day 28 at the final visit
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.
Adverse Events
Time Frame: day 28 at the final visit
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
Secondary Outcomes
- 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)
- Intraocular Pressure(day 28 at the final visit)
- Symptomatology Post Instillation(day 28 at the final visit)