Safety and Efficacy of a New Ophthalmic Formulation of Bi... | NCT01157364

ID	Type	Description	Link
2011-005091-42	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bimatoprost 20 µg generation 2, bimatoprost 0.03%	Other	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	Drug: bimatoprost 20 µg generation 2 Drug: bimatoprost 0.03%
bimatoprost 15 µg generation 2, bimatoprost 0.03%	Other	Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	Drug: bimatoprost 15 µg generation 2 Drug: bimatoprost 0.03%
bimatoprost 10 µg generation 2, bimatoprost 0.03%	Other	Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	Drug: bimatoprost 10 µg generation 2 Drug: bimatoprost 0.03%
bimatoprost 6 µg generation 2, bimatoprost 0.03%	Other	Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bimatoprost 20 µg generation 2	Drug	Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.	bimatoprost 20 µg generation 2, bimatoprost 0.03%

Measure	Description	Time Frame
Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.	Baseline, Month 24

Measure	Description	Time Frame
Time-Matched Intraocular Pressure (IOP) in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye.	Baseline to Month 6
Mean Diurnal IOP in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.

Name	Affiliation	Role
Medical Director	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sall Research Medical Center		Artesia	California	90701	United States
Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego

PubMed Identifier	Type	Citation	Retractions
31884564	Background	Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb;80(2):167-179. doi: 10.1007/s40265-019-01248-0.
35643967

ID	Title	Description
FG000	Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
FG001

Arm/Group Information

ID	Title	Description
BG000	Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
BG001	Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
BG002	Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
BG003	Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
BG004	Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
BG005	Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
BG006	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Excluding IOP assessments after rescue or retreatment.

Posted

Mean

Standard Deviation

Millimeters of Mercury (mmHg)

Baseline, Month 24

ID	Title	Description
OG000	Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG001	Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG002	Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG003	Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG004	Bimatoprost 15 μg Generation 1, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG005	Bimatoprost 10 μg Generation 1, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 μg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Units	Counts
Participants	OG00015 OG00121 OG00221 OG003

Title	Denominators	Categories
Baseline Hour 0,	ParticipantsOG00015 ParticipantsOG00121 ParticipantsOG00221 ParticipantsOG003

Secondary

Time-Matched Intraocular Pressure (IOP) in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye.

Posted

Mean

Standard Deviation

Millimeters of Mercury (mmHg)

Baseline to Month 6

ID	Title	Description
OG000	Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG001	Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG002	Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Secondary

Mean Diurnal IOP in the Study Eye

IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.

Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16. Including IOP assessments after rescue or retreatment.

Posted

Mean

Standard Deviation

mmHg

Baseline, Month 6

ID	Title	Description
OG000	Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG001	Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG002	Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%

Secondary

Time to Rescue Treatment or Re-Treatment in the Study Eye

Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.

Modified Intent-to-Treat: all treated patients with at least 1 IOP measurement at baseline and at least 1 postbaseline IOP measurement through Week 16

Posted

Median

Full Range

Days

24 Months

ID	Title	Description
OG000	Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG001	Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
OG002	Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bimatoprost 20 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	0	15	12	15
EG001	Bimatoprost 15 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	3	21	16	21
EG002	Bimatoprost 10 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	6	21	17	21
EG003	Bimatoprost 6 µg Generation 2, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	4	18	15	18
EG004	Bimatoprost 15 µg Generation 1, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	3	11	8	11
EG005	Bimatoprost 10 µg Generation 1, Bimatoprost 0.03%	Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.	3	23	21	23

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Carotid Artery Stenosis	Nervous system disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG0030 affected18 at risk EG0040 affected11 at risk EG0051 affected23 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Gastrointestinal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Malignant Ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Tonsil Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Large Intestine Polyp	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Retinal Detachment	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Cervical Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Urinary Incontinence	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Atrioventricular Block	Cardiac disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Non-cardiac Chest Pain	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Allergy to Arthropod Sting	Immune system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Neutropenic Sepsis	Infections and infestations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Mantle Cell Lymphoma Stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Hematemesis	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctival Hyperaemia	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0007 affected15 at risk EG0018 affected21 at risk EG0027 affected21 at risk EG0038 affected18 at risk EG0041 affected11 at risk EG0057 affected23 at risk
Foreign Body Sensation in Eyes	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected15 at risk EG0012 affected21 at risk EG0023 affected21 at risk EG003
Dry Eye	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected21 at risk EG0021 affected21 at risk EG003
Eye Pain	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected15 at risk EG0014 affected21 at risk EG0024 affected21 at risk EG003
Punctate Keratitis	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0003 affected15 at risk EG0012 affected21 at risk EG0023 affected21 at risk EG003
Conjunctival Haemorrhage	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected15 at risk EG0014 affected21 at risk EG0023 affected21 at risk EG003
Growth of Eyelashes	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected21 at risk EG0021 affected21 at risk EG003
Iris Hyperpigmentation	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Photophobia	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected15 at risk EG0013 affected21 at risk EG0024 affected21 at risk EG003
Vision Blurred	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected15 at risk EG0012 affected21 at risk EG0022 affected21 at risk EG003
Anterior Chamber Flare	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Blepharospasm	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Cataract	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Conjunctival Oedema	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Conjunctivitis Allergic	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Corneal Disorder	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Erythema of Eyelid	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected21 at risk EG0021 affected21 at risk EG003
Eyelid Margin Crusting	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Eyelid Oedema	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Eyelid Pain	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Eyelid Retraction	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Eyelid Pruritus	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Lacrimation Increased	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0015 affected21 at risk EG0023 affected21 at risk EG003
Macular Cyst	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Ocular Discomfort	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Optic Disc Haemorrhage	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Retinal Vein Occlusion	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Blepharitis	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Visual Acuity Reduced	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0021 affected21 at risk EG003
Anterior Chamber Inflammation	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Corneal Opacity	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Eye Irritation	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Eye Pruritus	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Iris Adhesions	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Lid Margin Discharge	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Orbit Atrophy	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Retinal Detachment	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Corneal Oedema	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Hyphaema	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Iritis	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Lagophthalmos	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Posterior Capsule Opacification	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Eyelid Ptosis	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Vitreous Detachment	Eye disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0021 affected21 at risk EG003
Intraocular Pressure Increased	Investigations	MedDRA version 19.0	Systematic Assessment	EG0004 affected15 at risk EG0012 affected21 at risk EG0022 affected21 at risk EG003
Blood Cholesterol Increased	Investigations	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Blood Pressure Increased	Investigations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Gamma-glutamyltransferase Increased	Investigations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Blood Glucose Increased	Investigations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Blood Potassium Decreased	Investigations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Heart Rate Irregular	Investigations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Blood Urine Present	Investigations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Influenza	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Sinusitis	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Ear Infection	Infections and infestations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0021 affected21 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Escherichia Sepsis	Infections and infestations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Neutropenic Sepsis	Infections and infestations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Oesophageal Candidiasis	Infections and infestations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Progressive Multifocal Leukoencephalopathy	Infections and infestations	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0022 affected21 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Headache	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Visual Field Defect	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Sciatica	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Large Intestine Polyp	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0011 affected21 at risk EG0022 affected21 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Upper-airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Allergic Sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Drug Hypersensitivity	Immune system disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Allergy to Arthropod Sting	Immune system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Muscle Strain	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Corneal Abrasion	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Cervical Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Transfusion Related Complication	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Aqueous Humour Leakage	Injury, poisoning and procedural complications	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Hypertension	Vascular disorders	MedDRA version 19.0	Systematic Assessment	EG0001 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Chest Pain	General disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Pyrexia	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Non-cardiac Chest Pain	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Corneal Dystrophy	Congenital, familial and genetic disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Prostatomegaly	Reproductive system and breast disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0021 affected21 at risk EG003
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Urinary Incontinence	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Insomnia	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Anxiety	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Depression	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Atrioventricular Block	Cardiac disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Mantle Cell Lymphoma Stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0010 affected21 at risk EG0020 affected21 at risk EG003
Hypotension	Vascular disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Phlebitis	Vascular disorders	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Gastrointestinal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003
Malignant Ascites	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Systematic Assessment	EG0000 affected15 at risk EG0011 affected21 at risk EG0020 affected21 at risk EG003

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D000577	Amides
D009930	Organic Chemicals
D003008	Cloprostenol
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated
D005227	Fatty Acids
D008055	Lipids
D012898	Autacoids
D018836	Inflammation Mediators
D001685	Biological Factors