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

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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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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