Purpose

The aim of this study is to compare the overall lens satisfaction between two soft multifocal contact lenses.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. They are at least 18 years of age. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction,) and have done so for at least the past three months. 4. They have a minimum reading add of +0.75DS (based on their spectacle refraction) 5. They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye. 6. They are able to achieve distance HCVA of +0.10 logMAR or better in each eye.

Exclusion Criteria

  1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are aphakic. 4. They have had corneal refractive surgery. 5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
omafilcon A lenses first, then low ADD power somofilcon A lens
Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.
  • Device: omafilcon A lens
    Participants will be randomized to wear omafilcon A lens for 15 minutes.
  • Device: Low ADD power somofilcon A lens
    Participants will be randomized to wear low ADD power somofilcon A lens for 15 minutes.
Experimental
omafilcon A lenses first, then medium ADD power somofilcon A lens
Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.
  • Device: omafilcon A lens
    Participants will be randomized to wear omafilcon A lens for 15 minutes.
  • Device: Medium ADD power somofilcon A lens
    Participants will be randomized to wear medium ADD power somofilcon A lens for 15 minutes.
Experimental
omafilcon A lenses first, then high ADD power somofilcon A lens
Participants will wear two different types of study contact lenses, in a randomized order of testing for the two study contact lens types.
  • Device: omafilcon A lens
    Participants will be randomized to wear omafilcon A lens for 15 minutes.
  • Device: High ADD power somofilcon A lens
    Participants will be randomized to wear high ADD power somofilcon A lens for 15 minutes.

Recruiting Locations

University of California, Berkeley, CA
Berkeley 5327684, California 5332921 94720
Contact:
Meng C Lin, OD, Ph.D
Mlin@berkeley.edu

More Details

NCT ID
NCT06869044
Status
Recruiting
Sponsor
CooperVision International Limited (CVIL)

Study Contact

Jose Vega, OD MSc, PhD
01-925-640-2964
JVega@coopervision.com

Detailed Description

The aim of the study is to evaluate the overall lens satisfaction between two soft multifocal contact lenses when compared to each other after 15 minutes of daily wear each.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.