Skip to main content
OpenTrials
Completed

NCT Number: NCT04016623

Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bloomington, Indiana, 47405, United States

About this study

A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.

Each subject will be asked to wear four pairs of contact lenses in the study

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.
  • Has clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination

Exclusion criteria

  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • 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 participating in any other type of eye related clinical or research study.

Treatment and study plan

1-day toric test contact lens

Device

somofilcon A 1-day toric test contact lens

Other names: Test contact lens, Invigor toric 1-day contact lens

1-day toric control contact lens

Device

somofilcon A 1-day toric control contact lens

Other names: Control contact lens

Primary outcomes

  1. Visibility of Toric Mark

    Time frame: 1 hour

    Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  2. Degree of Lens Orientation

    Time frame: Baseline

    Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  3. Degree of Lens Orientation

    Time frame: 15 minutes

    Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  4. Degree of Lens Orientation

    Time frame: 1 hour

    Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  5. Toric Stability

    Time frame: 15 minutes

    Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  6. Toric Stability

    Time frame: 1 hour

    Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  7. Degree of Rotational Recovery

    Time frame: 15 minutes

    Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  8. Degree of Rotational Recovery

    Time frame: 1 hour

    Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  9. Toric Fit Acceptance

    Time frame: 15 minutes

    Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  10. Toric Fit Acceptance

    Time frame: 1 hour

    Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  11. Toric Fit Preference

    Time frame: Baseline

    Investigator's toric fitting preference - Test lens , No Preference , Control lens.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  12. Toric Fit Preference

    Time frame: 1 hour

    Investigator's toric fitting preference - Test lens, No Preference, Control lens.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Secondary outcomes

  1. Measurement of Lens Horizontal Centration

    Time frame: 15 Minutes

    Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  2. Measurement of Lens Horizontal Centration

    Time frame: 1 hour

    Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  3. Measurement of Lens Vertical Centration

    Time frame: 15 minutes

    Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  4. Measurement of Lens Vertical Centration

    Time frame: 1 hour

    Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  5. Measurement of Lens Movement

    Time frame: 15 minutes

    Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  6. Measurement of Lens Movement

    Time frame: 1 hour

    Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  7. Lens Push-Up

    Time frame: 15 minutes

    Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  8. Lens Push-Up

    Time frame: 1 hour

    Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).

  9. Primary Lens Gaze Lag

    Time frame: 15 minutes

    Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  10. Primary Lens Gaze Lag

    Time frame: 1 hour

    Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  11. General Lens Fit Acceptance

    Time frame: 15 minutes

    General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  12. General Lens Fit Acceptance

    Time frame: 1 hour

    General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal).

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  13. Up Gaze Lag

    Time frame: 15 minutes

    Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  14. Up Gaze Lag

    Time frame: 1 hour

    Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  15. General Lens Fit Preference

    Time frame: Baseline

    Investigator's general lens fit preference - Test lens, No preference, Control lens.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

  16. General Lens Fit Preference

    Time frame: 1 hour

    Investigator's general lens fit preference - Test lens, No preference, Control lens.

    Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2019
Registry last updated
Aug 14, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.