A Study to Evaluate the Efficacy of Investigational OTC E... | NCT03198000

NCT03198000

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

Label	Type	Intervention Names
Formula # 13418-148	Experimental	Drug: F# 13418-148 Eye Drops
Formula # 13418-158	Experimental	Drug: F#13418-158 Eye Drops
Control Formula # PF004390	Active Comparator	Drug: F# PF-004390 Eye Drops

Name	Type	Description	Arm Group Labels	Other Names
F# 13418-148 Eye Drops	Drug	ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day	Formula # 13418-148

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application	Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.	Baseline to 60 seconds after first product application
Percentage of Participants With Response to Redness at 60 Seconds After First Product Application	The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.	Baseline to 60 seconds after first product application

Secondary Outcomes

Measure	Description	Time Frame
Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application	Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.	Baseline to 30 seconds after first product application

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
Able and willing to provide a signed and dated Informed Consent document and Authorization for the Release of Health Information for Research
Male or female of any race or ethnicity, aged 18 years and older;
Females of childbearing potential who have a negative urine pregnancy test at the Screening/Baseline visit (Visit 1);
Able to read and understand English;
Healthy subjects with redness in both eyes
History of topical ocular drugs or desire to use within the last 6 months;
Ocular health within normal limits,
Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Screening/Baseline Visit 1.

Exclusion Criteria:

Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
Known sensitivity, allergy or contraindications to any investigational product ingredient;
Females who are pregnant, planning to become pregnant or breastfeeding during the study;
Subjects who were previously screened and determined to be ineligible for the study;
Use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the Screening/Baseline visit (Visit 1) and throughout study participation;
Participation in any clinical study investigation within 30 days of Screening/Baseline visit (Visit 1);
Relative, partner or staff of any clinical research site personnel;
Active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection;
Any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy;
Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
Has a compromised immune system;
Has any acute or chronic, medical or psychiatric conditions
Contact lens use within 24 hours prior to clinic Visit 1 and during their participation in the study;
Saline eye drop use within 24 hours prior to clinic Visit 1 and during their participation in the study;
Use of any new OTC or prescription medications within 24 hours prior to clinic Visit 1 and throughout study participation.

Name	Affiliation	Role
Gail Torkildsen, MD	Andover Eye Associates	Principal Investigator

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

PubMed Identifier	Type	Citation	Retractions
20082509	Background	Cronau H, Kankanala RR, Mauger T. Diagnosis and management of red eye in primary care. Am Fam Physician. 2010 Jan 15;81(2):137-44.
8961843	Background	Hara JH. The red eye: diagnosis and treatment. Am Fam Physician. 1996 Dec;54(8):2423-30.

Arm/Group Information

ID	Title	Description
FG000	F#13418-148/F#13418-158	Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%
FG001	F#13418-148/F#PF004390	Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #PF004390 = tetrahydrozoline 0.05%
FG002	F#13418-158/F#PF004390	Eye drops - one formula in each eye: Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%; Formula #PF004390 = tetrahydrozoline 0.05%

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	F#13418-148/F#13418-158	Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%
BG001	F#13418-148/F#PF004390

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous		Intent-to-treat set

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

Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application

Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.

Intent-to-treat set

Posted

Mean

Standard Error

units on a scale

Baseline to 60 seconds after first product application

eyes

ID	Title	Description
OG000	F# PF004390 Eye Drops	Active Comparator - Tetrahydrozoline 0.05%
OG001	F# 13418-148 Eye Drops	Experimental - Tetrahydrozoline 0.05%; glycerin 0.40%

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	F#13418-148/F#13418-158	Eye drops - one formula in each eye: Formula #13418-148 = tetrahydrozoline 0.05%, glycerin 0.40%; Formula #13418-158 = tetrahydrozoline 0.05%, glycerin 0.20%, hypromellose 0.20%, polyethylene glycol 400 1.0%

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 28, 2017	Apr 27, 2023	Prot_002.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jun 19, 2017	Apr 27, 2023	SAP_003.pdf