Phase 2 Clinical Trial to Evaluate OC-01 Nasal Spray in S... | NCT04957758

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OC-01 (varenicline) nasal spray, 1.2 mg/mL	Active Comparator	OC-01 (varenicline) nasal spray, 1.2 mg/mL	Drug: OC-01 (varenicline) nasal spray 1.2 mg/ml
Placebo (vehicle control) nasal spray	Placebo Comparator	Placebo (vehicle control) nasal spray	Drug: Placebo (vehicle) nasal spray

Name	Type	Description	Arm Group Labels	Other Names
OC-01 (varenicline) nasal spray 1.2 mg/ml	Drug	OC-01	OC-01 (varenicline) nasal spray, 1.2 mg/mL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Corneal Fluorescein Staining	Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Visual Acuity at Week 8	Best Corrected Visual Acuity was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. ETDRS letters score range from 0 to 100 letters at each assessment. A higher score in ETDRS letters indicates a better outcome. A positive change from Baseline in ETDRS letter score indicates an improvement in visual acuity.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Dothan Alabama		Dothan	Alabama	36301	United States
Irvine, California

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL	OC-01 (varenicline) nasal spray, 1.2 mg/mL OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
FG001	Placebo (Vehicle Control) Nasal Spray

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	Nov 10, 2022	Mar 8, 2024

Arm/Group Information

ID	Title	Description
BG000	OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL	OC-01 (varenicline) nasal spray, 1.2 mg/mL OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
BG001	Placebo (Vehicle Control) Nasal Spray	Placebo (vehicle control) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle)
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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00065.3± 14.48 BG00161.5± 16.33 BG00263.3± 15.54

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00041 BG00147 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG00114 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Corneal Fluorescein staining Score

Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0002.29± 1.017 BG001

Best Correct Visual Acuity (Letters)

Best Corrected Visual Acuity was assessed based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. ETDRS letters score range from 0 to 100 letters at each assessment.

A higher score in ETDRS letters indicates a better outcome. A positive change from Baseline in ETDRS letter score indicates an improvement in visual acuity.

Mean

Standard Deviation

Number of letters

Title

Denominators

Categories

Title	Measurements
	BG00075.4± 14.42 BG001

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

Mean Change From Baseline in Corneal Fluorescein Staining

Corneal Fluorescein Staining was measured utilizing the Modified Oxford Grading scale. Scores range from a minimum of 0 (no staining) to a maximum of 5. A higher score indicates a worse outcome. The study eye is defined as the eye with the worst staining grade (if both eyes are eligible).

Per Protocol Population included all subjects in the intent to treat (ITT) population that had a baseline corneal fluorescein staining score >=2.

Posted

Least Squares Mean

Standard Error

score on a scale

8 weeks

ID	Title	Description
OG000	OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL	OC-01 (varenicline) nasal spray, 1.2 mg/mL OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
OG001	Placebo (Vehicle Control) Nasal Spray	Placebo (vehicle control) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle)

Units	Counts
Participants	OG00037 OG00145

Title

Denominators

Categories

Title	Measurements
	OG000-0.6± 0.17 OG001-0.9± 0.15

Secondary

Mean Change From Baseline in Visual Acuity at Week 8

A higher score in ETDRS letters indicates a better outcome. A positive change from Baseline in ETDRS letter score indicates an improvement in visual acuity.

Per Protocol Population included all subjects in the intent to treat (ITT) population that had a baseline corneal fluorescein staining score >=2.

Posted

Least Squares Mean

Standard Error

score on a scale

8 weeks

ID	Title	Description
OG000	OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL	OC-01 (varenicline) nasal spray, 1.2 mg/mL OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01
OG001	Placebo (Vehicle Control) Nasal Spray	Placebo (vehicle control) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle)

Units	Counts
Participants

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	OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL	OC-01 (varenicline) nasal spray, 1.2 mg/mL OC-01 (varenicline) nasal spray 1.2 mg/ml: OC-01	0	54	5	54	39	54
EG001	Placebo (Vehicle Control) Nasal Spray	Placebo (vehicle control) nasal spray Placebo (vehicle) nasal spray: Placebo (vehicle)	0	58	3	58	34	58

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Large Intestinal Obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected54 at risk EG0011 events1 affected58 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0000 events0 affected54 at risk EG0011 events1 affected58 at risk
Infective Exacerbation of bronchiectasis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected54 at risk EG0010 events0 affected58 at risk
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected54 at risk EG0010 events0 affected58 at risk
Skin Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected54 at risk EG0010 events0 affected58 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected54 at risk EG0011 events1 affected58 at risk
Femur Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected54 at risk EG0010 events0 affected58 at risk
Renal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected54 at risk EG0010 events0 affected58 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Corneal Dystrophy	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Asthenopia	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Cataract	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Corneal Degeneration	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Conjunctivochalasis	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Corneal epithelium defect	Eye disorders	Systematic Assessment	EG0004 affected54 at risk EG0011 affected58 at risk
Corneal erosion	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Corneal neovascularisation	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Corneal Opacity	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Diplopia	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Dry Eye	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0012 affected58 at risk
Erythema of eyelid	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Eye Discharge	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Eye Irritation	Eye disorders	Systematic Assessment	EG0002 affected54 at risk EG0011 affected58 at risk
Eye Pain	Eye disorders	Systematic Assessment	EG0002 affected54 at risk EG0011 affected58 at risk
Lacrimation Increased	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Meibomian Gland Dysfunction	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0011 affected58 at risk
Ocular Hyperaemia	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0012 affected58 at risk
Punctate Keratitis	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0012 affected58 at risk
Vision Blurred	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Visual Acuity Reduced	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Vitreous Floaters	Eye disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Disease Progression	General disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Pain	General disorders	Systematic Assessment	EG0000 affected54 at risk EG0013 affected58 at risk
Conjunctivitis	General disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Erythema of eyelid	Eye disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Eye Swelling	General disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Abdominal Pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Dry Mouth	Gastrointestinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0012 affected58 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected54 at risk EG0010 affected58 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Instillation Site Exfoliation	General disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Instillation Site Irritation	General disorders	Systematic Assessment	EG0004 affected54 at risk EG0012 affected58 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Gastroenteritis escherichia coli	Infections and infestations	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0001 affected54 at risk EG0011 affected58 at risk
Herpes Zoster	Infections and infestations	Systematic Assessment	EG0001 affected54 at risk EG0011 affected58 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Upper Respiratory Tract Infection	Infections and infestations	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Urinary Tract Infection	Infections and infestations	Systematic Assessment	EG0003 affected54 at risk EG0012 affected58 at risk
Vulvovaginal mycotic infection	Infections and infestations	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Ligament Sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Muscle Strain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Heart Rate Increased	Investigations	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Carpal Tunnel Syndrome	Nervous system disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Cervical Radiculopathy	Nervous system disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0002 affected54 at risk EG0012 affected58 at risk
Migraine	Nervous system disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Transient Ischaemic Attack	Nervous system disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Hypertonic Bladder	Renal and urinary disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected54 at risk EG0011 affected58 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Nasal Inflammation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0012 affected58 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected54 at risk EG0015 affected58 at risk
Nasal Oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0011 affected58 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00030 affected54 at risk EG0016 affected58 at risk
Throat Irritation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 affected54 at risk EG0010 affected58 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk
Trichorrhexis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected54 at risk EG0011 affected58 at risk
Hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected54 at risk EG0010 affected58 at risk

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D011810	Quinoxalines
D000336	Aerosols
D003102	Colloids
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations