A Comparison of Two Daily Disposable Soft Contact Lenses | NCT02427477

NCT02427477

Protocol Section

Identification Module

Results Section

Participant Flow 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

Status Module

Oversight 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
senofilcon A/ delefilcon A/ senofilcon A	Experimental	Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.	Device: senofilcon A Device: delefilcon A
delefilcon A/senofilcon A/ delfilcon A	Active Comparator	Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third.	Device: senofilcon A Device: delefilcon A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
senofilcon A	Device	Subjects will wear the contact lenses in both eyes for seven days	delefilcon A/senofilcon A/ delfilcon A senofilcon A/ delefilcon A/ senofilcon A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective Overall Comfort	Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.	1-week Follow-up
Subjective Overall Vision	Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.	1-week Follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must read, understand, and sign the Statement of Informed Consent, and receive a fully executed copy of the form.
The subject must be appear able and willing to adhere to instruction set forth in this clinical protocol.
The subject be between (and including) 18 and 39 years of age.
The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any autoimmune disease or use of any medication, which may interfere with contact lens wear.
Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular abnormality that may contraindicate contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Monovision, multifocal, toric, or extended wear contact lens correction.
Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.

Facility	Status	City	State	ZIP	Country	Contacts
		Montgomery	Alabama	36109	United States

Arm/Group Information

ID	Title	Description
FG000	Senofilcon A / Delefilcon A/ Senofilcon A	Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
FG001	Delefilcon A / Senofilcon A / Delefilcon A	Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Senofilcon A / Delefilcon A / Senofilcon A	All subjects that randomized to receive this sequence and were dispensed a study lens.
BG001	Delefilcon A / Senofilcon A / Delefilcon A

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

Subjective Overall Comfort

Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).

Posted

Mean

Standard Deviation

units on a scale

1-week Follow-up

Observations

ID	Title	Description
OG000

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	Senofilcon A	Subjects that received the senofilcon A contact lens in at least one of the three study periods.