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

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: somofilcon A multifocal lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519919

EX-MKTG-81

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Somofilcon A multifocal lens

Experimental group

Description:

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

Treatment:

Device: somofilcon A multifocal lens