Clinical Evaluation of Two Multifocal Contact Lenses

Presbyopia Clinical Trial

Official title:

Clinical Evaluation of Clariti Monthly Multifocal and Clariti 1 Day Multifocal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457608
• Other study ID #: EX-MKTG-136
• Status: Completed
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: August 13, 2022

Study information

• Verified date: September 2022
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 13, 2022
• Est. primary completion date: August 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lens A
monthly replacement multifocal silicone hydrogel contact lens 15 minutes of daily wear
• Lens B
daily disposable multifocal silicone hydrogel contact lens 15 minutes of daily wear

Locations

Country	Name	City	State
Mexico	School of Optometry Clinic, National Autonomous University (UNAM)	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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