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

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

• Lens A ( comfilcon A) (Device): Daily disposable, soft contact lenses worn for one month
• Lens B ( lehfilcon A) (Device): Daily disposable, soft contact lenses worn for one month

Primary outcomes

• Ease of handling [1 month]: Ease of handling for lens removal (0-100)

Sex: All, ages: 40 Years to any

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.