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

NCT03372551 | Completed Results FDA Device

• 1 other identifier: CV-16-43
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

somofilcon A 1 day test lens

EXPERIMENTAL

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; Device: somofilcon A 1 day control lens

somofilcon A 1 day control lens

ACTIVE COMPARATOR

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; Device: somofilcon A 1 day control lens

Interventions

somofilcon A 1 day test lens DEVICE

Contact lens

Also known as: somofilcon A daily disposable test soft contact lens, Invigor I, Test lens

somofilcon A 1 day control lens; somofilcon A 1 day test lens

somofilcon A 1 day control lens DEVICE

Contact lens

Also known as: somofilcon A daily disposable control soft contact lens, Select 1-Day, Control lens

somofilcon A 1 day control lens; somofilcon A 1 day test lens

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Myhanh Nguyen, Sr. Optometrist
• Organization: Coopervision

mnguyen@coopervision.com

925-730-6716

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 13, 2017
• Study Start: November 29, 2017
• Primary Completion: December 22, 2017
• Study Completion: April 23, 2018
• Last Updated: July 23, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)