Phase 3 N=178 Randomized Double-blind Treatment

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

Cataract

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View on ClinicalTrials.gov: NCT03693989 ↗

Enrolled (actual)

178

Serious AEs

0.6%

Results posted

Dec 2019

Primary outcome: Primary: Visual Ability (VA) — 0.91; 0.87 units on a scale (LogMAR) — p=0.065

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Difluprednate 0.05% (Drug); Prednefrin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Laboratorios Sophia S.A de C.V.
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Ability (VA)	0.91; 0.87	0.065
PRIMARY Adverse Events	93; 89	0.223
SECONDARY Cellularity in the Anterior Chamber	75; 76; 8; 6; 2; 4	0.621
SECONDARY Clinical Corneal Edema	85; 83; 0; 3; 0; 0	0.246
SECONDARY Flare	84; 86; 1; 0; 0; 0	0.497
SECONDARY Central Thickness of the Retina	253.59; 263.38	0.047 sig
SECONDARY Conjunctival Hyperemia	78; 73; 5; 11; 2; 2	0.300
SECONDARY Intraocular Pressure	13.88; 13.04	0.045 sig
SECONDARY Symptomatology Post Instillation	12; 8; 1; 0; 0; 2	0.346

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT03693989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.