Study: NCT02246764

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 34 at risk

Adverse event: Corneal Verticillata
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 34 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 34 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 34 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 34 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 34 at risk

Adverse event: Corneal opacity
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 34 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 34 at risk

Adverse event: Eye Pruritis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 34 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 34 at risk

Adverse event: Conjunctivochalasis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Eye allergy
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 34 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 6 affected / 34 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Instillation site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 14 affected / 34 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 34 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 34 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 34 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 34 affected / 36 at risk

Adverse event: Corneal Verticillata
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 36 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 36 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 36 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 36 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 36 at risk

Adverse event: Corneal opacity
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 36 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 36 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 36 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Eye Pruritis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Foreign Body Sensation in Eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 36 at risk

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Conjunctivochalasis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Eyelid pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Optic disc haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 36 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 8 affected / 36 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 36 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 23 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 23 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 23 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Optic disc haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 23 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 23 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 7 affected / 23 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk