Evaluation of the Effectiveness of ST266 Ophthalmic Drops... | NCT02978183

NCT02978183

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

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
Group 1	Active Comparator	1X ST266 dosed 4 times a day for 8 days	Biological: ST266
Group 2	Placebo Comparator	Placebo dosed 4 times a day for 8 days	Drug: Saline (0.9% NaCl)

Name	Type	Description	Arm Group Labels	Other Names
ST266	Biological	One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular Itching	Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.	Day 7 and 8
Conjunctival Redness	Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness.	Day 7 and 8

Secondary Outcomes

Measure	Description	Time Frame
Ciliary Redness	Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.	Day 7 and 8
Episcleral Redness

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be at least 18 years of age of either gender and any race;
provide written informed consent and sign the HIPAA form;
be willing and able to follow all instructions and attend all study visits; have a positive history of ocular allergies and a positive skin test reaction to a seasonal AND perennial allergen as confirmed by an allergic skin test;
be able and willing to avoid all disallowed medication for the appropriate washout period and during the study;
be able and willing to discontinue wearing contact lenses for at least 72 hours prior to and during the study trial period;
(for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at the study exit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration and for at least 14 days prior to instillation of investigational product). Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
have a positive post-CAC reaction;
have a positive post-CAC reaction in two out of the first three time points;
be able to self-administer eye drops satisfactorily or have a caregiver at home routinely available for this purpose.

Exclusion Criteria:

have known contraindications or sensitivities to the use of the investigational product or any of its components;
have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, or pterygium);
have had ocular surgical intervention within 3 months prior to initiating the study or during the study and/or a history of refractive surgery within the past 6 months;
have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit;
use any of the disallowed medications during the period indicated prior to and during the study;
have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease [including arrhythmias]) the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens);
manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the screening visit;
have planned surgery (ocular or systemic) during the trial period or within 30 days after;
have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;
be a female who is currently pregnant, planning a pregnancy, or lactating.
have cancer or have a history of cancer within the last 5 years.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
		Andover	Massachusetts	01810	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Group 1	1X ST266 dosed 4 times a day for 8 days ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
FG001	Group 2	Placebo dosed 4 times a day for 8 days Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00034 subjects FG00136 subjects
COMPLETED		FG00034 subjects FG00136 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Group 1	1X ST266 dosed 4 times a day for 8 days ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
BG001	Group 2

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Ocular Itching

Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching.

Pre-Conjunctival Allergen Challenge not evaluated in subject 1-011 on visit 5B

Posted

Mean

Standard Deviation

score on a scale

Day 7 and 8

ID	Title	Description
OG000	Group 1	1X ST266 dosed 4 times a day for 8 days ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
OG001	Group 2	Placebo dosed 4 times a day for 8 days Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.

Adverse Events Module

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	Group 1	1X ST266 dosed 4 times a day for 8 days ST266: One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Visual Acuity Reduced	Eye disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
David Steed, MD	Noveome Biotherapeutics, Inc	4124029913		dsteed@noveome.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 13, 2017	Mar 13, 2023	Prot_002.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jan 5, 2017	Mar 13, 2023	SAP_003.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D003233	Conjunctivitis, Allergic

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate

Intervention Browse Module

ID	Term
D012965	Sodium Chloride

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Masking Info

Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness.

Placebo dosed 4 times a day for 8 days

Saline (0.9% NaCl): One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.

EG0001 events1 affected34 at risk

EG0010 events0 affected36 at risk