Clinical Performance Evaluation of Two Silicone Hydrogel Lenses

Not Applicable

Completed

Conditions: Visual Acuity

Interventions: Device: TEST Contact Lens
Device: CONTROL Contact Lens

Registration Number: NCT02756078

Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary: This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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 and 40 years of age.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye.
The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane.
The subject must have best corrected visual acuity of 0.20 or better in each eye.
The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
The subject must be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day.
The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.
The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
The subject must meet normal eligibility conditions of binocular vision tests.
The subject may not have any double vision at near with their habitual contact lens correction.

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 (at the investigator's discretion).
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion).
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
Any active ocular infection.
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.).
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any known hypersensitivity or allergic reaction to the study products.
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.
Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1 (TEST / CONTROL wear sequence)	CONTROL Contact Lens	Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
Group 2 (CONTROL / TEST wear sequence)	CONTROL Contact Lens	Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
Group 1 (TEST / CONTROL wear sequence)	TEST Contact Lens	Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
Group 2 (CONTROL / TEST wear sequence)	TEST Contact Lens	Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.

Primary Outcome Measures

Name	Time	Method
Overall CLUE Comfort	Up to 4-Week Follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Overall CLUE Handling	Up to 4-Week Follow-up	Overall Handling 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.
Time to Haze	Up to 4-Week Follow-up	Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision.
Average Comfortable Wear Time	Up to 4-Week Follow-up	Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit.
Difference in Total Device Use Time and Comfortable Wear Time During Device Use	Up to 4-Week Follow-up	Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use.
Average Wear Time	Up to 4-Week Follow-up	Average lens wear time with the study lenses were recorded in hour at each follow-up visit.
Comfort at the End of the Day	Up to 4-Week Follow-up	Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type.