Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses

The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: somofilcon A 1 day test lens; Device: somofilcon A 1 day control lens

Detailed Description

The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has had a self-reported oculo-visual examination in the last two years;
• Has read, understood, and signed the information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
• Must be able to achieve 20/30 or better (in each eye) with the study lenses;
• Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
• Requires spectacle lens powers between -0.75 and -06.50 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.

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 enrolment (by verbal confirmation at the screening visit).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: somofilcon A 1 day test lens; Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.	Device: somofilcon A 1 day test lens; Contact lens; Other Names: Test lens; somofilcon A daily disposable test soft contact lens; Invigor I; Device: somofilcon A 1 day control lens; Contact lens; Other Names: somofilcon A daily disposable control soft contact lens; Select 1-Day; Control lens
ACTIVE_COMPARATOR: somofilcon A 1 day control lens; Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.	Device: somofilcon A 1 day test lens; Contact lens; Other Names: Test lens; somofilcon A daily disposable test soft contact lens; Invigor I; Device: somofilcon A 1 day control lens; Contact lens; Other Names: somofilcon A daily disposable control soft contact lens; Select 1-Day; Control lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)	up to 1 week
Preference	Overall lens that subject prefers or no preference	up to 1 week
Vision	Visual acuity measured in logMAR	Up to 1 week
Subjective Vision	Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)	up to 1 week
Corneal Staining	Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps	up to 1 week
Conjunctival Staining	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps	up to 1 week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2017
• Primary Completion (ACTUAL): December 22, 2017
• Study Completion (ACTUAL): April 23, 2018

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (ACTUAL): December 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-16-43

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.: Yes