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Completed

NCT Number: NCT03951610

A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Center at Ketchum Health, Anaheim, California, United States

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About this study

The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
  • Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
  • Has no more than 0.75 diopters of refractive astigmatism.
  • Has clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination.
  • Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Exclusion criteria

  • Is presently participating in any other clinical or research study including eye related clinical or research study.
  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
  • Has any known sensitivity to fluorescein dye or products to be used in the study.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).

Treatment and study plan

Test lens

Device

contact lens

Other names: Invigor I DD lens, Somofilcon A 1 day Test

Control lens

Device

contact lens

Other names: Clariti 1-day, Somofilcon A 1 day control

Primary outcomes

  1. Number of Participants With Lens Centration

    Time frame: Baseline

    Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)

  2. Number of Participants With Lens Centration

    Time frame: 1 week

    Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)

  3. Post Blink Movement

    Time frame: Baseline

    Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

  4. Post Blink Movement

    Time frame: 1 week

    Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

  5. Primary Gaze Lag

    Time frame: baseline

    Primary Gaze Lag (measured in mm at 0.1mm steps)

  6. Primary Gaze Lag

    Time frame: 1 week

    Primary Gaze Lag (measured in mm at 0.1mm steps)

  7. Up Gaze Lag

    Time frame: Baseline

    Up Gaze Lag (measured in mm at 0.1mm steps)

  8. Up Gaze Lag

    Time frame: 1 week

    Up Gaze Lag (measured in mm at 0.1mm steps)

  9. Push-Up Tightness

    Time frame: baseline

    Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

  10. Push-Up Tightness

    Time frame: 1 week

    Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

  11. Overall Fit Acceptance

    Time frame: Baseline

    Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

  12. Overall Fit Acceptance

    Time frame: 1 week

    Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

  13. Number of Participants With Overall Lens Fit Impression

    Time frame: Baseline

    Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

  14. Number of Participants With Overall Lens Fit Impression

    Time frame: 1 week

    Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

Secondary outcomes

  1. Subjective Comfort Rating

    Time frame: Baseline

    Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)

  2. Subjective Comfort Rating

    Time frame: 1-week

    Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 15, 2019
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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