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

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Test Lens
Device: Control Lens

Registration Number: NCT03235089

Lead Sponsor: Coopervision, Inc.

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nelfilcon A lens (control)	Test Lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Test lens	Control Lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
Test lens	Test Lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).
nelfilcon A lens (control)	Control Lens	Each subjects will wear a test lens in one eye and the control lens in the other as an unmatched pair, per predetermined randomization schedule (to determine which eye receives test/control lens).

Primary Outcome Measures

Name	Time	Method
Lens Tightness Assessed by Push-up Test	6-hours	Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule	6 hours	Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Overall Lens Fit Acceptance	6 hours	Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Vertical Lens Centration Assessed in Primary Gaze	6-hours	Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule	6 hours	Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Up Gaze Lag Assessed Observing Lens Movement in Graticule	6 hours	Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink	6 hours	Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Horizontal Lens Centration Assessed in Primary Gaze	6-hour	Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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Bloomington, Indiana, United States