Clinical Evaluation of Two Approved Contact Lenses

Johnson & Johnson Vision Care, Inc.13 sites in 1 country283 target enrollmentApril 1, 2016

ConditionsVisual Acuity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.
Enrollment: 283
Locations: 13
Primary Endpoint: Overall Quality of Vision
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.

Registry

clinicaltrials.gov

Start Date

April 1, 2016

End Date

June 1, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Johnson & Johnson Vision Care, Inc.

Responsible Party

Sponsor

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 (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.
•Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
•Have refractive astigmatism, if present, of less than or equal to 1.00 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 medication, which may interfere with contact lens wear.
•Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
•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.
•Monovision, multi-focal, 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.

Outcomes

Primary Outcomes

Overall Quality of Vision

Time Frame: 7-Day Follow-up

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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.

Overall Comfort

Time Frame: 7-Day 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.