28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension

Exclusion Criteria

• •Any clinically significant disease or concomitant medication that would interfere with the study evaluation.
• •Patients with advanced glaucoma at risk of progression during the study in the opinion of the Investigator.
• •Presence or history of hypersensitivity to latanoprost or known history of non-response to any prostaglandin analog given for the reduction of IOP.
• •History of hypersensitivity or allergy to any component of the investigational medicinal product or any of the diagnostic medications or materials used in the conduct of the study.
• •Use or expected need for ocular (topical, periocular, or intravitreal), local (inhaled or nasal), or systemic glucocorticoid medications within 4 weeks prior to the baseline visit and for the duration of the study.
• •Any vaccination within the last 28 days from randomization or during screening whichever is longer.
• •Any patient in the exclusion period of a previous study according to applicable regulations.
• •Any patient who cannot be contacted in case of emergency.
• •Any patient who is the Investigator or any subinvestigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
• •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
• •Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates) unless the result of a medical prescription.
• •An IOP ≥36 mmHg at any time during the screening, baseline, or randomization visits (Day 1 predose).
• •History of ocular surgery (including laser) or trauma in either eye within 6 months of the screening visit.
• •History of glaucoma filtering surgery or aqueous shunt procedures (traditional valves and/or microinvasive glaucoma surgery \[MIGs\]).
• •History of ocular infection within the past 3 months or ongoing or recurrent ocular inflammation (ie, moderate to severe blepharitis, allergic conjunctivitis, herpetic keratitis, peripheral ulcerative keratitis, scleritis, or uveitis) in either eye. Any ocular abnormalities or symptoms indicative of ongoing ophthalmic disease (except if related to glaucoma or OHT).
• •Central corneal thickness \<500 µm or \>620 µm at the baseline visit.
• •Any evidence of cornea guttata or corneal endothelial dysfunction from medical history or at the baseline visit.
• •Uncontrolled disease that would interfere with the study conduct, the interpretation of the study results, or the ability of the patient to meet the requirements of the study schedule.
• •Any corneal abnormalities preventing reliable applanation tonometry.
• •Closed/barely open anterior chamber angle or a history of acute angle closure in either eye not adequately treated with a peripheral iridectomy.
• •Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, advanced age-related macular degeneration, inherited retinal dystrophies) in either eye.
• •Advanced optic nerve abnormality or history of visual field loss in either eye based on the assessment of the Investigator which could put the patient at risk of glaucoma progression by participating in the study.
• •History of aphakia, pseudophakia with a torn posterior lens capsule, macular edema, or known risk factors for macular edema in either eye.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.