Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study

NCT03519919 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-81
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• Vision Clarity During the Day - Distance Vision

  Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3

  Baseline

• Vision Clarity During the Day - Distance Vision

  Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3

  3 weeks

Secondary Outcomes (30)

• Number of Participants With Lens Centration

  Baseline

• Number of Participants With Lens Centration

  3 weeks

• Visual Acuity

  Baseline

• Visual Acuity

  3 weeks

• Post-blink Lens Movement

  Baseline

Study Arms (1)

Somofilcon A multifocal lens

EXPERIMENTAL

Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.

Device: somofilcon A multifocal lens

Interventions

somofilcon A multifocal lens DEVICE

contact lens

Also known as: clarifi multifocal lens

Somofilcon A multifocal 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 read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Has had a self-reported oculo-visual examination in the last two years.
• Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
• Presently wears lenses for minimum wear 4 days/week and 10 hours/day
• Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
• Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
• Current refraction indicates a reading addition of +1.50 or higher
• Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
• Spends 10 hrs or more indoors at least 5 days/week
• Possesses a smartphone and is willing to download the MetricWire app to receive

You may not qualify if:

• Is presently wearing Clariti 1 day multifocal lenses
• Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
• Is participating in any concurrent clinical or research study;
• Has any known active\* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Has known sensitivity to fluorescein dye or products to be used in the study;
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
• Is aphakic;
• Has undergone refractive error surgery;
• Is an employee of the Centre for Contact Lens Research

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

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, O.D., MSc., FAAO
• Organization: CooperVision.Inc

javega@coopervision.com

9256213761

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 9, 2018
• Study Start: August 21, 2017
• Primary Completion: September 22, 2018
• Study Completion: February 15, 2019
• Last Updated: December 19, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-12

Locations

CA (1)