Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

NCT04016623 | Completed Results FDA Device

• 1 other identifier: CV-19-27
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (16)

• Measurement of Lens Horizontal Centration

  15 Minutes

• Measurement of Lens Horizontal Centration

  1 hour

• Measurement of Lens Vertical Centration

  15 minutes

• Measurement of Lens Vertical Centration

  1 hour

• Measurement of Lens Movement

  15 minutes

Study Arms (2)

1-day toric test contact lens

EXPERIMENTAL

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; Device: 1-day toric control contact lens

1-day toric control contact lens

ACTIVE COMPARATOR

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; Device: 1-day toric control contact lens

Interventions

1-day toric test contact lens DEVICE

somofilcon A 1-day toric test contact lens

Also known as: Test contact lens, Invigor toric 1-day contact lens

1-day toric control contact lens; 1-day toric test contact lens

1-day toric control contact lens DEVICE

somofilcon A 1-day toric control contact lens

Also known as: Control contact lens

1-day toric control contact lens; 1-day toric test contact lens

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

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

Astigmatism

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Myhanh Nguyen
• Organization: CooperVision, Inc.

mnguyen@coopervision.com

925-730-6716

Study Officials

• Pete S Kollbaum, OD PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: July 11, 2019
• Study Start: May 6, 2019
• Primary Completion: May 15, 2019
• Study Completion: June 4, 2019
• Last Updated: August 14, 2020
• Results First Posted: August 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)