Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Johnson & Johnson Vision Care, Inc.157 enrolled

Overview

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

157

Conditions

Myopia

Interventions

Narafilcon B Contact LensDEVICE

SpectaclesDEVICE

spectacle wearers

Eligibility

Sex: ALLMin age: 15 YearsMax age: 39 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate). * Willing to comply with the study visit schedule. * Ages 15 to 39. * Has access to a cellular telephone with text messaging capabilities. * Has a current pair of spectacles. * 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'. * Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC. * Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye. * Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week. * They agree not to participate in other clinical research during the duration of this study. Exclusion Criteria: * Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear. * Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus). * Systemic disease, which might interfere with contact lens wear. * Medication usage that may be associated with eye dryness. * Use of any topical medication such as eye drops or ointment. * Pregnant or lactating (by self-report). * Aphakia. * Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear. * Have participated in any other clinical trial or research in the two weeks prior to starting this study.

Locations (1)

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Papillary Conjunctivitis

Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Time frame: 1 Year

Conjunctival Hyperemia

Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Time frame: 1 Year

Limbal Hyperemia

Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Time frame: 1 Year

Corneal Staining

Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.

Time frame: 1 Year

Conjunctival Staining

Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

Data from ClinicalTrials.gov

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Assessment of Daily Disposable Silicone Hydrogel Lens Wear

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes