Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers

Clinical Performance Evaluation of Two Monthly Replacement Silicone Hydrogel Multifocal Toric Lens Designs in Habitual Soft Contact Lens Wearers

To compare the performance of two leading soft multifocal Toric contact lenses.

Study Overview

• Status: Not yet recruiting
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Lens A ( comfilcon A); Device: Lens B ( lehfilcon A)

Detailed Description

Prospective, randomized, subject-masked, bilateral crossover dispensing study.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liandra Jung; Phone Number: +19253948002; Email: liandra.jung@coopervision.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 13850
      • Sacco Eye Group
      • Contact: Staci Sacco; Phone Number: 6077981987; Email: researchcoordinator@saccoresearch.com
      • Principal Investigator: Andrew Sacco, OD
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center
      • Principal Investigator: Katherine Bickle, OD
      • Contact: Katherine Bickle; Phone Number: 7405873937; Email: kbickle12@yahoo.com
  • Texas
    • Corpus Christi, Texas, United States, 78411
      • Drs. Mcintyre Garza Avila & Jurica
      • Contact: Alissa Shawver; Phone Number: 3619940310; Email: alissa@cccontacts.com
      • Principal Investigator: David Browning, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A person is eligible for inclusion in the study if they are:

1. Participants at least 40 years of age.
2. Participants requiring lens powers within the range available for the study lenses.
3. Participants with a spherical refractive error at the corneal plane of plano to -6.00.
4. Participants with a minimum reading add of +0.75DS (based on their spectacle refraction at screening). At least 12 participants will be enrolled per add group: low (+0.75 to +1.25D), medium (+1.50 to +1.75D), and high (+2.00 to +2.50).
5. Participants with refractive astigmatism at the corneal plane of 0.75 to 2.00DC.
6. Best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0.1).
7. Habitually using soft contact lenses (multifocal soft contact lenses, sphere or toric lenses for monovision, or sphere or toric lenses for distance vision correction and spectacles for near vision correction) and have worn lenses at least 3 days a week for at least the past six months.
8. Anticipating being able to wear contact lenses for at least 8 hours a day, 5 days a week.
9. Willing and able to follow instructions and maintain the appointment schedule.

Exclusion Criteria:

1. Anterior segment infection, inflammation or abnormality that would contraindicate contact lens wear.
2. Any active anterior segment ocular disease that would contraindicate contact lens wear.
3. The use of systemic or ocular medications that would contraindicate contact lens wear.
4. History of herpetic keratitis.
5. History of refractive surgery or irregular cornea.
6. Slit lamp findings that are more serious than grade 1 (see ISO 11980 scale).
7. Inactive (i.e. ghost) vessels greater than 1 mm of penetration into the cornea.
8. Participation of the participant in a contact lens or contact lens care product clinical trial within the previous 90 days if involving orthokeratology, 30 days if involving extended wear, rigid gas permeable corneal and scleral lenses, or 15 days if involving daily disposable, daily wear soft lenses.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A then Lens B; Participants will wear the Test Lenses in both eyes for one month and then cross over to the Control Lenses in both eyes for one month.	Device: Lens A ( comfilcon A); Daily disposable, soft contact lenses worn for one month
Experimental: Lens B and then Lens A; Participants will wear the Control Lenses in both eyes for one month and then cross over to the Test Lenses in both eyes for one month.	Device: Lens B ( lehfilcon A); Daily disposable, soft contact lenses worn for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of handling	Ease of handling for lens removal (0-100)	1 month

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 15, 2026
• First Submitted That Met QC Criteria: September 15, 2026
• First Posted (Actual): September 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism
• Other Study ID Numbers: MKTG-26-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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