A Phase III Study Assessing the Efficacy and Safety of DE... | NCT03691649

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DE-117 Ophthalmic Solution	Experimental	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only	Drug: DE-117 Ophthalmic Solution
Timolol Maleate Ophthalmic Solution 0.5%	Active Comparator	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only	Drug: Timolol Maleate Ophthalmic Solution 0.5%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DE-117 Ophthalmic Solution	Drug	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular Pressure at Week 1	Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)	08:00, 10:00 and 16:00 at Week 1
Intraocular Pressure at Week 6	Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)	08:00, 10:00 and 16:00 at Week 6
Intraocular Pressure at Month 3	Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)	08:00, 10:00 and 16:00 at Month 3

Secondary Outcomes

Measure	Description	Time Frame
Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)	Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.	Month 3
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Glaucoma Specialists		Phoenix	Arizona	85050	United States
DocTrials Walman Eye Center

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 months for adult subjects only. DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 months for adult subjects only.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 13, 2018	Jun 27, 2023

Arm/Group Information

ID	Title	Description
BG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
BG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0006 BG0017 BG00213
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.7± 14.91 BG00163.5± 14.48 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000123 BG001135 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000212 BG001213 BG002

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

Intraocular Pressure at Week 1

Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)

Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1.

Posted

Least Squares Mean

Standard Error

mmHg

08:00, 10:00 and 16:00 at Week 1

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Units	Counts
Participants	OG000212 OG001213

Title

Denominators

Categories

8:00

- ParticipantsOG000210
- ParticipantsOG001211

Title	Measurements
	OG00019.0± 0.22

Primary

Intraocular Pressure at Week 6

Posted

Least Squares Mean

Standard Error

mmHg

08:00, 10:00 and 16:00 at Week 6

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Primary

Intraocular Pressure at Month 3

Posted

Least Squares Mean

Standard Error

mmHg

08:00, 10:00 and 16:00 at Month 3

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Secondary

Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)

Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.

Posted

Least Squares Mean

Standard Error

mmHg

Month 3

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Secondary

Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)

Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)

Posted

Least Squares Mean

Standard Error

mmHg

08:00, 10:00 and 16:00 at Week 1

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Secondary

Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)

Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)

Posted

Least Squares Mean

Standard Error

mmHg

08:00, 10:00 and 16:00 at Week 6

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Secondary

Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)

Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)

Posted

Least Squares Mean

Standard Error

mmHg

08:00, 10:00 and 16:00 at Month 3

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Secondary

Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)

Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.

Mean Diurnal IOP at week 1 is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.

Posted

Least Squares Mean

Standard Error

mmHg

Week 1

ID	Title	Description
OG000	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
OG001	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DE-117 Ophthalmic Solution (Double Masked Treatment Period)	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only DE-117 Ophthalmic Solution: Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only	0	211	4	211	61	211
EG001	Timolol Maleate Ophthalmic Solution 0.5% (Double Masked Treatment Period)	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only Timolol Maleate Ophthalmic Solution 0.5%: Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only	1	215	5	215	47	215
EG002	DE-117 Ophthalmic Solution (Open Label Treatment Period)	Topical DE-117 Ophthalmic Solution once daily for 9 months for adult subjects only (Period 2)	1	377	12	377	85	377

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cystoid macular	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected211 at risk EG0010 affected215 at risk EG0023 affected377 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected211 at risk EG0010 affected215 at risk EG0020 affected377 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected211 at risk EG0010 affected215 at risk EG0020 affected377 at risk
Pneumonia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected211 at risk EG0010 affected215 at risk EG0022 affected377 at risk
Influenza Type A test positive	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0011 affected215 at risk EG0020 affected377 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0011 affected215 at risk EG0020 affected377 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0011 affected215 at risk EG0020 affected377 at risk
Cerebral hemorrhage	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0021 affected377 at risk
Acute Cardiac event	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0021 affected377 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0021 affected377 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0021 affected377 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0021 affected377 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0021 affected377 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0021 affected377 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0011 affected215 at risk EG0020 affected377 at risk
Dizziness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected211 at risk EG0010 affected215 at risk EG0020 affected377 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0011 affected215 at risk EG0020 affected377 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctival hyperaemia	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG00013 affected211 at risk EG00110 affected215 at risk EG00212 affected377 at risk
Vision blurred	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG00011 affected211 at risk EG0013 affected215 at risk EG00214 affected377 at risk
Photophobia	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG00010 affected211 at risk EG0011 affected215 at risk EG0024 affected377 at risk
Ocular hyperaemia	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected211 at risk EG0014 affected215 at risk EG0020 affected377 at risk
Dry eye	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected211 at risk EG0012 affected215 at risk EG0020 affected377 at risk
Eye pain	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected211 at risk EG0015 affected215 at risk EG0026 affected377 at risk
Visual impairment	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected211 at risk EG0010 affected215 at risk EG0020 affected377 at risk
Eye irritation	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected211 at risk EG0018 affected215 at risk EG0024 affected377 at risk
Vitreous detachment	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected211 at risk EG0011 affected215 at risk EG0020 affected377 at risk
Vitreous floaters	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected211 at risk EG0010 affected215 at risk EG0026 affected377 at risk
Growth of eyelashes	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected211 at risk EG0013 affected215 at risk EG0025 affected377 at risk
Macular oedema	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0029 affected377 at risk
Cystoid macular oedema	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0029 affected377 at risk
Punctate keratitis	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0027 affected377 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0024 affected377 at risk
Eyelash changes	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0024 affected377 at risk
Eyelash hyperpigmentation	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0024 affected377 at risk
Eyelash thickening	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0024 affected377 at risk
Sinusitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0025 affected377 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0025 affected377 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0013 affected215 at risk EG0024 affected377 at risk
Nasopharyngitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0014 affected215 at risk EG0020 affected377 at risk
Instillation site pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected211 at risk EG00112 affected215 at risk EG0020 affected377 at risk
Vital dye staining cornea present	Investigations	MedDRA (21.1)	Systematic Assessment	EG0007 affected211 at risk EG0015 affected215 at risk EG0028 affected377 at risk
Headache	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected211 at risk EG0012 affected215 at risk EG0020 affected377 at risk
Hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected211 at risk EG0010 affected215 at risk EG0024 affected377 at risk