Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Male or female, age 18 years or older on day of consent
Participants with routine unilateral cataract surgery on the day prior to study randomization
Participants with at least 5 cells in anterior chamber on the first day after surgery (at Baseline visit)
Willing and able to understand and provide written informed consent form (ICF) (at Screening visit)

Women who satisfy one of the following:

Are of child-bearing potential who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly, like hormonal contraception (oral pills, implantable device, or skin patch), intrauterine device, bilateral tubal occlusion, or double barrier) for at least 4 weeks prior to Baseline visit and throughout the study (i.e., until Day 29),

OR

Are post-menopausal (have had no menstrual cycle for at least one year prior to Screening visit) or have undergone a sterilization procedure (bilateral tubal ligation, hysterectomy, hysterectomy with unilateral or bilateral oophorectomy or bilateral oophorectomy) at least 6 months prior to Screening visit

Exclusion Criteria:

Systemic administration of any corticosteroid or immunosuppressant drugs in the previous 2 weeks prior to the first instillation of the investigational medical product (IMP)
Periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to the first instillation of the IMP, or of any corticosteroid depot within 2 months prior to the first instillation of the IMP (Ozurdex® [dexamethasone]: within prior 6 months; Iluvien® [fluocinolone]: within prior 36 months)
Instillation of any topical ocular corticosteroid, non-steroidal antiinflammatory drug (NSAID), mast cells stabilizers, antihistamines or decongestants within 2 weeks prior to the first instillation of the IMP, except pre-surgical and/or surgical administration of 1 drop of a topical NSAID or corticosteroid, at the investigator discretion
Prescription of any topical ocular medication, except preservative-free antibiotics for prophylactic purposes
Any history of glaucoma or ocular hypertension in the study eye
History or presence of endogenous uveitis
Any current corneal abrasion or ulceration
Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease
Known hypersensitivity or contraindication to the study drug or any of its components
History of steroid-related intraocular pressure (IOP) increase
Previous surgery in the last 4 weeks prior to the Screening visit or new surgery scheduled to be performed before the end of the study period on the contralateral eye
Presence of ocular hemorrhage which interferes with the evaluation of post-surgery inflammation
Presence of intraoperative complications during the cataract surgical procedure that may increase post-operative inflammation; this includes, in particular, patients with ocular hemorrhage, floppy iris syndrome, increased IOP (≥24 mmHg), posterior capsule rupture and injections of gas into the vitreous body
Increased cumulative dissipated energy value during phacoemulsification (increased energy used for phacoemulsification exert additional stress on iris and other anterior chamber structures and may generate excessive inflammation)
Presence of zonular dialysis (rupture of zonular fibers that attach lens to the ciliar body which may lead to partial luxation of the lens / lens capsule and is a serious complication of cataract surgery)
Presence of Fuchs´ endothelial dystrophy (loss of endothelial cells that may result in chronic corneal edema after cataract surgery especially if high energy was used during phacoemulsification)
Presence of cornea guttata
Pupil dilation lower than 4.5 mm
Presence of lower lacrimal duct obstruction and/or history of infectious dacryocystitis
Presence of IOP ≥24 mmHg at Baseline visit
Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to the Screening visit, or at any time during the study
Prior participation in the study described in this protocol, unless patient was not randomized
In the opinion of the investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
Disease, condition (including monocular participants), or disorder that in the judgement of investigator could confound study assessments or limit compliance to study protocol