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

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Test lens; Device: Control lens

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92807
      • University Eye Center at Ketchum Health
  • 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 (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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test lens; Subjects wearing the test lens for one week, either randomized as the first or second pair.	Device: Test lens; contact lens; Other Names: Invigor I DD lens; Somofilcon A 1 day Test; Device: Control lens; contact lens; Other Names: Clariti 1-day; Somofilcon A 1 day control
Active Comparator: Control lens; Subjects wearing the control lens for one week, either randomized as the first or second pair.	Device: Test lens; contact lens; Other Names: Invigor I DD lens; Somofilcon A 1 day Test; Device: Control lens; contact lens; Other Names: Clariti 1-day; Somofilcon A 1 day control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Lens Centration	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)	Baseline
Number of Participants With Lens Centration	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)	1 week
Post Blink Movement	Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)	Baseline
Post Blink Movement	Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)	1 week
Primary Gaze Lag	Primary Gaze Lag (measured in mm at 0.1mm steps)	baseline
Primary Gaze Lag	Primary Gaze Lag (measured in mm at 0.1mm steps)	1 week
Up Gaze Lag	Up Gaze Lag (measured in mm at 0.1mm steps)	Baseline
Up Gaze Lag	Up Gaze Lag (measured in mm at 0.1mm steps)	1 week
Push-Up Tightness	Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)	baseline
Push-Up Tightness	Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)	1 week
Overall Fit Acceptance	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	Baseline
Overall Fit Acceptance	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	1 week
Number of Participants With Overall Lens Fit Impression	Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable	Baseline
Number of Participants With Overall Lens Fit Impression	Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort Rating	Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)	Baseline
Subjective Comfort Rating	Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)	1-week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): June 4, 2019

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-19-01

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