Two monthly silicone hydrogel multifocal toric contact lenses in wearers with astigmatism and myopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, subject-masked, bilateral crossover study comparing Lens A (comfilcon A) and Lens B (lehfilcon A) in soft contact lens wearers. Eligible participants are 40 years or older with myopia up to -6.00 diopters, astigmatism 0.75 to 2.00 diopters, and a reading add of at least +0.75 diopters. Each participant will wear both lenses in a randomized sequence, allowing direct comparison of performance. The study collects outcomes such as visual acuity and comfort to determine relative performance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Drs. Mcintyre Garza Avila & Jurica
  Corpus Christi, Texas, United States Recruiting
• Sacco Eye Group
  New York, New York, United States Not yet recruiting
• ProCare Vision Center
  Granville, Ohio, United States Not yet recruiting

Study contacts

• Study coordinator: Liandra Jung
• Email: liandra.jung@coopervision.com
• Phone: +19253948002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.