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

NCT07829419 | Not Yet Recruiting FDA Device

• 1 other identifier: MKTG-26-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Astigmatism; Myopia

Outcome Measures

Primary Outcomes (1)

• Ease of handling

  Ease of handling for lens removal (0-100)

  1 month

Study Arms (2)

Lens A then Lens B

EXPERIMENTAL

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)

Lens B and then Lens A

EXPERIMENTAL

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)

Interventions

Lens A ( comfilcon A) DEVICE

Daily disposable, soft contact lenses worn for one month

Lens A then Lens B

Lens B ( lehfilcon A) DEVICE

Daily disposable, soft contact lenses worn for one month

Lens B and then Lens A

Eligibility Criteria

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

You may qualify if:

• Participants at least 40 years of age.
• Participants requiring lens powers within the range available for the study lenses.
• Participants with a spherical refractive error at the corneal plane of plano to -6.00.
• 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).
• Participants with refractive astigmatism at the corneal plane of 0.75 to 2.00DC.
• Best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0.1).
• 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.
• Anticipating being able to wear contact lenses for at least 8 hours a day, 5 days a week.
• Willing and able to follow instructions and maintain the appointment schedule.

You may not qualify if:

• Anterior segment infection, inflammation or abnormality that would contraindicate contact lens wear.
• Any active anterior segment ocular disease that would contraindicate contact lens wear.
• The use of systemic or ocular medications that would contraindicate contact lens wear.
• History of herpetic keratitis.
• History of refractive surgery or irregular cornea.
• Slit lamp findings that are more serious than grade 1 (see ISO 11980 scale).
• Inactive (i.e. ghost) vessels greater than 1 mm of penetration into the cornea.
• 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.

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead

Study Sites (3)

Sacco Eye Group

New York, New York, 13850, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Drs. Mcintyre Garza Avila & Jurica

Corpus Christi, Texas, 78411, United States

Location

MeSH Terms

Conditions

Astigmatism; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Liandra Jung

CONTACT

+19253948002; liandra.jung@coopervision.com

Study Design

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

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)