Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

Johnson & Johnson Vision Care, Inc.72 enrolled

Overview

The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Contact Lens Base Curve (BC) Fit and Comfort

Interventions

Contact Lenses with 8.5 BCDEVICE

Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.

Contact Lenses with 9.0 BCDEVICE

Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 no less than 18 and no more than 45 years of age with no presbyopic add. * The subject must be willing and able to adhere to the instructions set out in the protocol. * The subject must be an adapted soft contact lens wearer in both eyes. * The subject must be willing to wear the study contact lenses up to 14 hours/day. * The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye. * The subject must have refractive cylinder less than or equal to 1.00 D in each eye. * The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye. * The subject must require a visual correction in both eyes (no monofit or monovision allowed). * The subject must have normal eyes (i.e., no ocular medications or infections of any type). Exclusion Criteria: * Current 1-DAY ACUVUE® TruEye® wearers * Anisometropia of 1.00 D or greater * Any Ocular or systemic allergies or diseases which might interfere with contact lens wear. * Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear. * 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 ocular infection * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear * Pregnancy or lactation * Diabetes * Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). * Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Locations (2)

Unnamed facility

Jacksonville, Florida, United States

Unnamed facility

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Correlation Between Subjective CLUE Comfort and Keratometry

CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter \[DK\]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.

Time frame: 3-day follow-up

Correlation Between Subjective CLUE Comfort and Corneal Diameter

Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter \[HVID\]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.

Time frame: 3-day follow-up

Data from ClinicalTrials.gov

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