Clinical Study of Approved and Investigational Contact Le... | NCT02708524

Label	Type	Description	Intervention Names
Senofilcon C Wearers	Experimental	Senofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days.	Device: Senofilcon C Contact Lens
Comfilcon A Wearers	Active Comparator	Comfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days.	Device: Comfilcon A Contact Lens
Lotrafilcon B Wearers	Active Comparator	Lotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days.	Device: Lotrafilcon B Contact Lens
Samfilcon A Wearers	Active Comparator	Samfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days.	Device: Samfilcon A Contact Lens

Name	Type	Description	Arm Group Labels	Other Names
Senofilcon C Contact Lens	Device		Senofilcon C Wearers	senofilcon C
Comfilcon A Contact Lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective Overall Comfort Composite Score	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.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.	Up to 1 month Follow-up
Overall Comfort Individual Item	Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.	1 month follow-up
Comfort at the End of the Day Individual Item	Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.	1 month Follow-up
Comfort Each and Everyday Individual Item	Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.	1 month Follow-up
Frequency of Lens Awareness Individual Item

Secondary Outcomes

Measure	Description	Time Frame
Subjective Overall Quality of Vision Composite Score	Subjective Overall Quality of Vision 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. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.

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 appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be between 18 to 40 years of age at the time of consent.
The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
The subject's refractive cylinder must be ≤1.00D in each eye.
The subject must have best corrected visual acuity of 20/30 or better in each eye.
The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

Currently pregnant or lactating (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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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 corneal inflammatory event (e.g., past peripheral ulcer or round peripheral 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.
Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

ID	Title	Description
FG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
FG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.

ID	Title	Description
BG000	Senofilcon C	All subjects that wore the senofilcon C lens throughout the duration of the study.
BG001	Comfilcon A	All subjects that wore the comfilcon A lens throughout the duration of the study.
BG002	Lotrafilcon B	All subjects that wore the lotrafilcon B lens throughout the duration of the study.
BG003	Samfilcon A	All subjects that wore the samfilcon A lens throughout the duration of the study.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000139 BG001136 BG002137 BG003136 BG004548

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 Composite Score

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.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.

All subjects that completed all study visits without a major protocol deviation.

Posted

Mean

Standard Deviation

average clue score

Up to 1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Units	Counts
Participants	OG000134 OG001130 OG002133 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00065.17± 23.612 OG00168.58± 21.993 OG00266.45± 22.864 OG003

Primary

Overall Comfort Individual Item

Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

1 month follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Primary

Comfort at the End of the Day Individual Item

Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Primary

Comfort Each and Everyday Individual Item

Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Primary

Frequency of Lens Awareness Individual Item

Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Primary

Frequency of Experiencing Dryness Individual Item

Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Primary

Making Your Eyes Feel Moist Throughout the Day Individual Item

Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

Up to 1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A

Secondary

Subjective Overall Quality of Vision Composite Score

Subjective Overall Quality of Vision 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. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.

Subjects that completed all study visits without a major protocol deviation.

Posted

Mean

Standard Deviation

units on a scale

Up to 1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.

Secondary

Overall Quality of Vision Individual Item

Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

Up to 1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Secondary

Overall Opinion Individual Item

Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

Subjects that completed all study visits without a major protocol deviation.

Posted

Number

percentage of participants

Up to 1 month Follow-up

ID	Title	Description
OG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
OG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
OG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
OG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.

Facility	Status	City	State	ZIP	Country	Contacts
		Montgomery	Alabama		United States

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Senofilcon C	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	0	139	139
EG001	Comfilcon A	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.	0	136	136
EG002	Lotrafilcon B	Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.	0	137	137
EG003	Samfilcon A	Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.	1	136	136