Multifocal Contact Lenses Fitting Methods Comparison

NCT05734846 | Completed Results FDA Device

• 1 other identifier: CV-22-49
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

• 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

• Overall Lens Preference

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

  Two weeks

Secondary Outcomes (2)

• Overall Binocular Visual Acuity Index

  One week

• Number of Contact Lenses

  One week

Study Arms (2)

Control Lenses, then Test Lenses

EXPERIMENTAL

Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week.

Device: Control Lenses (control fitting approach); Device: Test Lenses (test fitting approach)

Test Lenses, then Control Lens

EXPERIMENTAL

Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week.

Device: Control Lenses (control fitting approach); Device: Test Lenses (test fitting approach)

Interventions

Control Lenses (control fitting approach) DEVICE

Daily wear multifocal lenses for 1 week

Control Lenses, then Test Lenses; Test Lenses, then Control Lens

Test Lenses (test fitting approach) DEVICE

Daily wear multifocal lenses for 1 week

Control Lenses, then Test Lenses; Test Lenses, then Control Lens

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Ocular Technology Group - International

London, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Percy Lazon de la Jara BOptom PhD
• Organization: CooperVision Inc.

PLazon@coopervision.com

+1-925-251-6682

Study Officials

• Michel Guillon, PhD, FCOptom

  Ocular Technology Group - International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: October 11, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-02

Locations

GB (1)