Initial Evaluation of Investigational Lenses Manufactured... | NCT03679741

NCT03679741

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEST/CONTROL/CONTROL	Experimental	Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks.	Device: CONTROL Lens Device: TEST Lens
CONTROL/TEST/TEST	Experimental	Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks.	Device: CONTROL Lens Device: TEST Lens

Name	Type	Description	Arm Group Labels	Other Names
CONTROL Lens	Device	Acuvue OASYS	CONTROL/TEST/TEST TEST/CONTROL/CONTROL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Comfort Score	Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.	2-Week Follow-up
Vision Satisfaction in Bright Lighting	Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. 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 with a range of 0-120. The Proportion of responses in each category were reported for each lens type.	2-Week Follow-up
Distance Monocular LogMAR Visual Acuity	Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination > 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination <2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.	2-Week Follow-up
Contact Lens Fitting Acceptance Rate

Secondary Outcomes

Measure	Description	Time Frame
Overall Quality of Vision Score	Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must read and sign the Informed Consent form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and -6.00 D.
The subject's refractive cylinder must be ≤ 1.00 D in each eye.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
Subjects must own a wearable pair of spectacles.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
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 intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (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 corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Toric, extended wear, monovision or multi-focal contact lens correction.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
History of binocular vision abnormality or strabismus.
Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Facility	Status	City	State	ZIP	Country	Contacts
Randall Go, OD		San Francisco	California	94110	United States
VRC-East

ID	Title	Description
FG000	Test/Control/Control	Subjects that were randomized to receive the test lens during the first period and the control lens during both the second and third periods.
FG001	Control/Test/Test	Subjects that were randomized to receive the control lens during the first period and the test lens during both the second and third periods.

ID	Title	Description
BG000	All Dispensed Subjects	All subjects dispensed at least one study lens regardless of randomization.

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

Overall Comfort Score

Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.

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

Posted

Mean

Standard Deviation

Units on a Scale

2-Week Follow-up

ID	Title	Description
OG000	Test	Subjects that wore the Test lens during any of the three periods during the study.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Nov 14, 2018	Nov 4, 2019	SAP_000.pdf
Prot	Yes	No	No	Study Protocol	Aug 9, 2018	Nov 4, 2019	Prot_001.pdf