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

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).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Test Lens; Device: Control Lens

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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).	Device: Test Lens; Daily disposable contact lens; Device: Control Lens; Focus Dailies All Day Comfort contact lens (nelfilcon A)
ACTIVE_COMPARATOR: nelfilcon A lens (control); 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).	Device: Test Lens; Daily disposable contact lens; Device: Control Lens; Focus Dailies All Day Comfort contact lens (nelfilcon A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	6-hours
Primary Gaze Lag Assessed Observing Lens Movement in Graticule	Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)	Baseline
Primary Gaze Lag Assessed Observing Lens Movement in Graticule	Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)	6 hours
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule	Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)	Baseline
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule	Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)	6 hours
Overall Lens Fit Acceptance	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)	Baseline
Overall Lens Fit Acceptance	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)	6 hours
Up Gaze Lag Assessed Observing Lens Movement in Graticule	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).	Baseline
Up Gaze Lag Assessed Observing Lens Movement in Graticule	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).	6 hours
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink	Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink	Baseline
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink	Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink	6 hours

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2017
• Primary Completion (ACTUAL): August 3, 2017
• Study Completion (ACTUAL): August 3, 2017

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (ACTUAL): August 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-17-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes