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

NCT03235089 | Completed Results FDA Device

• 1 other identifier: CV-17-46
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Myopia

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

Test lens

ACTIVE COMPARATOR

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; Device: Control Lens

nelfilcon A lens (control)

ACTIVE COMPARATOR

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; Device: Control Lens

Interventions

Test Lens DEVICE

Daily disposable contact lens

Test lens; nelfilcon A lens (control)

Control Lens DEVICE

Focus Dailies All Day Comfort contact lens (nelfilcon A)

Test lens; nelfilcon A lens (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

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

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Lee Hall, BSc, PhD, MCOptom, FBCLA
• Organization: CooperVision, Inc

lhall@coopervision.com

925 251 6684

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both subject and investigator will be masked to lens type for each eye. A different investigator will select the study lenses for insertion by the subject, from those performing the assessments in order to maintain masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: July 25, 2017
• Primary Completion: August 3, 2017
• Study Completion: August 3, 2017
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)