A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

CooperVision, Inc.31 enrolled

Overview

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

Test LensDEVICE

Daily disposable contact lens

Control LensDEVICE

Focus Dailies All Day Comfort contact lens (nelfilcon A)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Is at least 18 years of age and has full legal capacity to volunteer * Has read, fully understood and signed the information consent letter * Currently wears or has previously worn soft contact lenses * Has spectacle cylinder ≤1.00D in both eyes. * Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes. * Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye. * Has clear corneas and no active ocular disease * Is willing and able to follow product usage instructions and maintain the visit schedule. Exclusion Criteria: * Has never worn contact lenses before * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable * Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable * Has any known active ocular disease and/or infection * Has a monovision correction * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses * Is aphakic * Has undergone corneal refractive surgery * Is pregnant or lactating, determined by self-report

Locations (1)

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Horizontal Lens Centration Assessed in Primary Gaze

Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

Time frame: Baseline

Horizontal Lens Centration Assessed in Primary Gaze

Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

Time frame: 6-hour

Vertical Lens Centration Assessed in Primary Gaze

Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

Time frame: Baseline

Vertical Lens Centration Assessed in Primary Gaze

Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)

Time frame: 6-hours

Lens Tightness Assessed by Push-up Test

Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

Time frame: Baseline

Lens Tightness Assessed by Push-up Test

Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)

Time frame: 6-hours

Primary Gaze Lag Assessed Observing Lens Movement in Graticule

Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)

Time frame: Baseline

Data from ClinicalTrials.gov

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