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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372551
• Other study ID #: CV-16-43
• Status: Completed
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: April 23, 2018

Study information

• Verified date: July 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 23, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• somofilcon A 1 day test lens
Contact lens
• somofilcon A 1 day control lens
Contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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