DW Evaluation of Lotrafilcon B Lenses in a Modified Design

Alcon Research134 enrolled

Overview

The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

134

Conditions

Myopia

Interventions

Lotrafilcon B sphere modified design contact lensesDEVICE

Lotrafilcon B sphere contact lensesDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must sign an Informed Consent Document; * Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule; * Manifest cylinder less than or equal to 0.75 D; * Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance; * Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses; * Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes; * Other protocol-defined criteria may apply. Exclusion Criteria: * Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week); * Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear; * History of herpetic keratitis; * History of corneal or refractive surgery or irregular cornea; * A pathologically dry eye that precludes contact lens wear; * Monocular (only one eye with functional vision); * Monovision correction; * History of intolerance or hypersensitivity to any component of the test articles or associated materials; * Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days; * Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment; * Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study; * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes

With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.

Time frame: Dispense (Day 0), Week 1

Data from ClinicalTrials.gov

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