Evaluation of Wear Experience With Daily Contact Lenses | NCT05096156

NCT05096156

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

Name	Class
Alcon Research	INDUSTRY

Oversight Module

Description 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
All participants are fit with the study daily disposable lenses	Experimental	All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses.	Device: Precision1® Daily Disposable Contact Lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Precision1® Daily Disposable Contact Lens	Device	Soft, spherical contact lens used to correct distance vision.	All participants are fit with the study daily disposable lenses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective Assessment of Precision1® Daily Disposable Contact Lens	Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)	2 weeks

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
The Ohio State University College of Optometry		Columbus	Ohio	43210	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	All Participants Are Fit With the Study Daily Disposable Lenses	All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	All Participants Are Fit With the Study Daily Disposable Lenses	All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.

Units	Counts
Participants	BG000

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

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

Subjective Assessment of Precision1® Daily Disposable Contact Lens

Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms)

Posted

Median

Inter-Quartile Range

units on a scale

2 weeks

ID	Title	Description
OG000	All Participants Are Fit With the Study Daily Disposable Lenses	All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses. Precision1® Daily Disposable Contact Lens: Soft, spherical contact lens used to correct distance vision.

Units

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	All Participants	All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the Verofilcon A daily disposable study contact lenses.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Jennifer Fogt, OD MS, Principal Investigator	The Ohio State University College of Optometry	16142928858		OPT-EyeStudies@osu.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 22, 2021	Nov 6, 2023	Prot_SAP_002.pdf