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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: 1-day toric test contact lens; Device: 1-day toric control contact lens

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

• Study Type: Interventional
• Enrollment (Actual): 10
• 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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Control contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visibility of Toric Mark	Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Degree of Lens Orientation	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).	Baseline
Degree of Lens Orientation	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).	15 minutes
Degree of Lens Orientation	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).	1 hour
Toric Stability	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).	15 minutes
Toric Stability	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).	1 hour
Degree of Rotational Recovery	Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Degree of Rotational Recovery	Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Toric Fit Acceptance	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).	15 minutes
Toric Fit Acceptance	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).	1 hour
Toric Fit Preference	Investigator's toric fitting preference - Test lens , No Preference , Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	Baseline
Toric Fit Preference	Investigator's toric fitting preference - Test lens, No Preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Lens Horizontal Centration	Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 Minutes
Measurement of Lens Horizontal Centration	Measurement of Lens Horizontal Centration in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Measurement of Lens Vertical Centration	Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Measurement of Lens Vertical Centration	Lens Horizontal centration measured in mm. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Measurement of Lens Movement	Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Measurement of Lens Movement	Measurement of lens movement in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
Lens Push-Up	Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Lens Push-Up	Lens push-up measured in percentage. Data for all 4 pairs were combined and analyzed (n=40 control lenses).	1 hour
Primary Lens Gaze Lag	Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Primary Lens Gaze Lag	Primary lens gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
General Lens Fit Acceptance	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).	15 minutes
General Lens Fit Acceptance	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).	1 hour
Up Gaze Lag	Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	15 minutes
Up Gaze Lag	Up gaze lag measured in millimeters. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).	1 hour
General Lens Fit Preference	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).	Baseline
General Lens Fit Preference	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).	1 hour

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Pete S Kollbaum, OD PhD, Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2019
• Primary Completion (ACTUAL): May 15, 2019
• Study Completion (ACTUAL): June 4, 2019

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (ACTUAL): July 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CV-19-27

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.: No