Safety and Efficacy Study of R932348 Ophthalmic Solution... | NCT02040623

NCT02040623

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
R348 Ophthalmic Solution, 0.2%	Active Comparator	R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day	Drug: R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%	Active Comparator	R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day	Drug: R348 Ophthalmic Solution, 0.5%
Placebo	Placebo Comparator	Placebo Ophthalmic Solution 2 drops per eye twice a day	Other: Placebo Ophthalmic Solution

Name	Type	Description	Arm Group Labels	Other Names
R348 Ophthalmic Solution, 0.2%	Drug	R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day	R348 Ophthalmic Solution, 0.2%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.	Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.	Baseline to 12 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Rigel Pharmaceuticals, Inc.	Rigel Pharmaceuticals,Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
U. Miami - Bascom Palmer Eye Institute		Plantation	Florida	33324	United States
Massachusetts Eye and Ear Infirmary

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
FG001	R348 Ophthalmic Solution, 0.5%

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day

R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
BG001	R348 Ophthalmic Solution, 0.5%	R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
BG002	Placebo	Placebo Ophthalmic Solution 2 drops per eye twice a day Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00011 BG00112 BG00212 BG00335

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-4.2± 2.9 OG001-6.2± 3.7 OG002-2.1± 2.6

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day	1	11	11	11
EG001	R348 Ophthalmic Solution, 0.5%	R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day	2	12	10	12
EG002	Placebo	Placebo Ophthalmic Solution 2 drops per eye twice a day Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day	1	12	9	12

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hyperbilirubinaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Clostridium Difficile infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0021 events1 affected12 at risk
Acute Kidney Injury	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Microembolism	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hyperbilirubinaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Ocular Hyperaemia	Eye disorders	Non-systematic Assessment	EG0004 events2 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Blepharitis	Eye disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0012 events1 affected12 at risk EG0020 events0 affected12 at risk
Corneal Deposits	Eye disorders	Non-systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Dry Eye	Eye disorders	Non-systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Eye Irritation	Eye disorders	Non-systematic Assessment	EG0002 events1 affected11 at risk EG0012 events1 affected12 at risk EG0022 events1 affected12 at risk
Foreign Body Sensation in Eyes	Eye disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Posterior Capsule Opacification	Eye disorders	Non-systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Punctate Keratitis	Eye disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0013 events2 affected12 at risk EG0022 events2 affected12 at risk
Trichiasis	Eye disorders	Non-systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Cataract	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Cataract Nuclear	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Conjunctival Haemorrhage	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Conjunctival Hyperaemia	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0022 events1 affected12 at risk
Conjunctivitis	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Corneal Opacity	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Diplopia	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected12 at risk EG0020 events0 affected12 at risk
Eye Pain	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0021 events1 affected12 at risk
Eyelid Ptosis	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Iris Adhesions	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0021 events1 affected12 at risk
Keratitis	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Meibomian Gland Dysfunction	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0022 events1 affected12 at risk
Optic Nerve Cupping	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Retinal Pigmentation	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events1 affected12 at risk
Vision Blurred	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected12 at risk EG0020 events0 affected12 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0013 events1 affected12 at risk EG0020 events0 affected12 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Vomitting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Instillation Site Pain	General disorders	Non-systematic Assessment	EG0004 events2 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Instillation Site Foreign Body Sensation	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected12 at risk EG0020 events0 affected12 at risk
Secretion Discharge	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0012 events1 affected12 at risk EG0020 events0 affected12 at risk
Cholangitis Sclerosing	Hepatobiliary disorders	Non-systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Seasonal Allergy	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Graft Versus Host Disease	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected11 at risk EG0010 events0 affected12 at risk EG0021 events1 affected12 at risk
Arthritis Bacterial	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Oral Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0021 events1 affected12 at risk
Skin Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Urinary Tract Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Clostridium Difficile Infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Dacryocystitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0021 events1 affected12 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0013 events3 affected12 at risk EG0020 events0 affected12 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0022 events2 affected12 at risk
Arthropod Bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Intraocular Pressure Increased	Investigations	Non-systematic Assessment	EG0002 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Blood Triglycerides Increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Seizure	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Restlessness	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Insomnia	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Acute Kidney Injury	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Parosmia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Respiratory Tract Irritation	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected12 at risk EG0020 events0 affected12 at risk
Microembolism	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected12 at risk EG0021 events1 affected12 at risk
Ecchymosis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected12 at risk EG0020 events0 affected12 at risk
Hyperaemia	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected12 at risk EG0021 events1 affected12 at risk

Title	Organization	Phone	Extension	Email
Anne-Marie Duliege, MD	Rigel	650-624-1100		clinicaltrials@rigel.com

ID	Term
D000092122	Bronchiolitis Obliterans Syndrome
D007638	Keratoconjunctivitis Sicca

Ancestor Terms

ID	Term
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D006086	Graft vs Host Disease
D007154	Immune System Diseases
D007637	Keratoconjunctivitis
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D007634	Keratitis
D003316	Corneal Diseases
D015352	Dry Eye Syndromes
D007766	Lacrimal Apparatus Diseases