Clinical Evaluation of Two Multifocal Contact Lenses

NCT05457608 | Completed Results DMC FDA Device

• 1 other identifier: EX-MKTG-136
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lens A

EXPERIMENTAL

All participants wore lens A for 15 minutes (Period 1)

Device: Lens A

Lens B

EXPERIMENTAL

All participants wore lens B for 15 minutes (Period 2)

Device: Lens B

Interventions

Lens A DEVICE

monthly replacement multifocal silicone hydrogel contact lens 15 minutes of daily wear

Lens A

Lens B DEVICE

daily disposable multifocal silicone hydrogel contact lens 15 minutes of daily wear

Lens B

Eligibility Criteria

• Age: 42 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

School of Optometry Clinic, National Autonomous University (UNAM)

Mexico City, Mexico

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega,OD,MSc,FAAO
• Organization: CooperVision

jvega2@coopervision.com

9256213761

Study Officials

• Rubén V Guerrero, MSc, FIACLE

  School of Optometry, National Autonomous University (UNAM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: All participants received Lens A and then Lens B in fixed-sequence order.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: June 25, 2022
• Primary Completion: August 13, 2022
• Study Completion: August 13, 2022
• Last Updated: December 20, 2023
• Results First Posted: September 21, 2023

Record last verified: 2022-09

Locations

ME (1)