Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

CIBA VISION40 enrolled

Overview

The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

Delefilcon A contact lensDEVICE

Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear

Etafilcon A contact lensDEVICE

Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Normal eyes with no use of ocular medications. * Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document. * Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps). * Visual acuity with study lenses 20/25 or better. * Cylinder less than or equal to 0.75 D. * Currently wearing daily disposable lenses. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Anterior segment infection, inflammation, or abnormality. * Any active anterior segment ocular disease that would contraindicate contact lens wear. * Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator. * History of refractive surgery or irregular cornea. * Eye injury within twelve weeks immediately prior to enrollment for this trial. * Currently enrolled in any clinical trial. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)

As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.

Time frame: 1 week of wear, replacing lenses daily

Overall Comfort

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Time frame: 1 week of wear, replacing lenses daily

Overall Vision Quality

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Time frame: 1 week of wear, replacing lenses daily

Overall Handling

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.

Time frame: 1 week of wear, replacing lenses daily

Secondary Outcomes

Overall Lens Fit

As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.

Data from ClinicalTrials.gov

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