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Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

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ClinicalTrials.gov Identifier: NCT04016623
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Astigmatism Device: 1-day toric test contact lens Device: 1-day toric control contact lens Not Applicable

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a non-dispensing, double-masked, randomized, contralateral study design. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
Actual Study Start Date : May 6, 2019
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : June 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: 1-day toric test contact lens
Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).
Device: 1-day toric test contact lens
somofilcon A 1-day toric test contact lens
Other Names:
  • Test contact lens
  • Invigor toric 1-day contact lens

Device: 1-day toric control contact lens
somofilcon A 1-day toric control contact lens
Other Name: Control contact lens

Active Comparator: 1-day toric control contact lens
Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).
Device: 1-day toric test contact lens
somofilcon A 1-day toric test contact lens
Other Names:
  • Test contact lens
  • Invigor toric 1-day contact lens

Device: 1-day toric control contact lens
somofilcon A 1-day toric control contact lens
Other Name: Control contact lens




Primary Outcome Measures :
  1. Visibility of Toric Mark [ Time Frame: Up to 1 hour ]
    Toric Mark visible or not visible

  2. Degree of Lens Orientation [ Time Frame: Up to 1 hour ]
    Location of toric marks from the 6 o'clock location - measured in degrees

  3. Degree of Rotational Stability [ Time Frame: Up to 1 hour ]
    Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes

  4. Degree of Rotational Recovery [ Time Frame: Up to 1 hour ]
    Rotational Recovery for nasal and temporal - measured in degrees

  5. Toric Fit Acceptance and Preference Scale [ Time Frame: Up to 1 hour ]
    Toric fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal)


Secondary Outcome Measures :
  1. Measurement of Lens Centration [ Time Frame: Up to 1 hour of wear ]
    Lens centration measured in mm

  2. Measurement of Lens Movement [ Time Frame: Up to 1 hour of wear ]
    Lens movement measured in mm

  3. Percentage of Lens Push-Up [ Time Frame: Up to 1 hour of wear ]
    Lens push-up percentage

  4. Measurement of Lens Lag [ Time Frame: Up to 1 hour ]
    Lens lag measured in mm

  5. Lens Fit Acceptance and Preference scale [ Time Frame: Up to 1 hour ]
    General lens fit acceptance and preference scale 0-4 (0 = unacceptable, 4 = optimal)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016623


Locations
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United States, Indiana
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Coopervision, Inc.
Investigators
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Principal Investigator: Pete S Kollbaum, OD PhD Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

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Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT04016623     History of Changes
Other Study ID Numbers: CV-19-27
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases