Clinical Evaluation of Two Multifocal Contact Lenses

Clinical Evaluation of Clariti Monthly Multifocal and Clariti 1 Day Multifocal

The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lens A; Device: Lens B

Detailed Description

This is a single-blind, interventional, prospective, direct refit, bilateral wear study.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • School of Optometry Clinic, National Autonomous University (UNAM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 42 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Is at least 42 years of age and has full legal capacity to volunteer.
• Has read and signed an information consent letter.
• Self-reports having a full eye examination in the previous two years.
• Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Habitually wears multifocal soft contact lenses, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, for the past 3 months minimum.
• Has refractive astigmatism no higher than -0.75DC.
• Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D.
• Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS).

Exclusion Criteria:

• Is participating in any concurrent clinical or research study.
• Has any known active ocular disease and/or infection that contraindicates contact lens wear.
• 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 contact lens wear or a study outcome variable.
• Has known sensitivity to the diagnostic sodium fluorescein used in the study.
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
• Has undergone refractive error surgery or intraocular surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A; All participants wore lens A for 15 minutes (Period 1)	Device: Lens A; monthly replacement multifocal silicone hydrogel contact lens 15 minutes of daily wear
Experimental: Lens B; All participants wore lens B for 15 minutes (Period 2)	Device: Lens B; daily disposable multifocal silicone hydrogel contact lens 15 minutes of daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort Ratings on Insertion	Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel.	At insertion

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Rubén V Guerrero, MSc, FIACLE, School of Optometry, National Autonomous University (UNAM)

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2022
• Primary Completion (Actual): August 13, 2022
• Study Completion (Actual): August 13, 2022

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: EX-MKTG-136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes