Study: NCT02674854

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 126 affected / 244 at risk

Adverse event: Cornea verticillata
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 244 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 244 at risk

Adverse event: Corneal disorder
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 244 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 42 affected / 244 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 15 affected / 244 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 8 affected / 244 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 255 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 255 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 255 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Vertebral artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 255 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 102 affected / 255 at risk

Adverse event: Cornea verticillata
Serious: no
Organ System: Eye disorders
Frequency: 25 affected / 255 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 255 at risk

Adverse event: Corneal disorder
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 255 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 255 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 16 affected / 255 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 13 affected / 255 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 251 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 251 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 251 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 51 affected / 251 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 251 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 251 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 251 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 10 affected / 251 at risk