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OpenTrials
Completed

NCT Number: NCT05734846

Multifocal Contact Lenses Fitting Methods Comparison

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ocular Technology Group - International

London, SW1E 6AU, United Kingdom

About this study

This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 40 years old;
  • Have read and understood the Participant Information Sheet;
  • Have read, signed and dated the Informed Consent;
  • Best corrected visual acuity of at least 20/25 in each eye;
  • Have normal eyes with the exception of the need for visual correction;
  • Current multifocal contact lens wearer;
  • Spectacle refraction:

Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D & +1.75D

  • Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion criteria

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
  • Monocular participants (only one eye with functional vision) or participants fit with only one lens;
  • Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
  • History of herpetic keratitis, ocular surgery or irregular cornea;
  • Known pregnancy or lactation during the study period;
  • Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

Treatment and study plan

Control Lenses (control fitting approach)

Device

Daily wear multifocal lenses for 1 week

Test Lenses (test fitting approach)

Device

Daily wear multifocal lenses for 1 week

Primary outcomes

  1. Overall Vision Satisfaction

    Time frame: One week

    Overall vision satisfaction for each lens was measured on a 0-100 point Visual Analog Scale (VAS), where 0=Extremely Unsatisfied and 100=Extremely Satisfied

  2. Overall Lens Preference

    Time frame: Two weeks

    Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'

Secondary outcomes

  1. Overall Binocular Visual Acuity Index

    Time frame: One week

    Mean binocular visual performance for each lens was measured by timed logMAR charts. Overall binocular logMAR visual acuity index was calculated by taking the mean of distance and near visual acuities

  2. Number of Contact Lenses

    Time frame: One week

    This measured the ease of fitting each contact lens. It counted the number of contact lenses (pair), selected as per the fitting guide, used to determine the final contact lens to dispense.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Biofinity Multifocal Contact Lenses Fitting Methods Comparison

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2023
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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