Multifocal Contact Lenses Fitting Methods Comparison

Presbyopia Clinical Trial

Official title:

Biofinity Multifocal Contact Lenses Fitting Methods Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05734846
• Other study ID #: CV-22-49
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Control Lenses (control fitting approach)
Daily wear multifocal lenses for 1 week
• Test Lenses (test fitting approach)
Daily wear multifocal lenses for 1 week

Locations

Country	Name	City	State
United Kingdom	Ocular Technology Group - International	London

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Vision Satisfaction	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	One week
Primary	Overall Lens Preference	Participants selected their preferred lens fitting approach from options - 'Control', 'Test', or 'No Preference'	Two weeks
Secondary	Overall Binocular Visual Acuity Index	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	One week
Secondary	Number of Contact Lenses	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.	One week