Comparing two daily disposable multifocal contact lenses

Performance of Two Daily Disposable Multifocal Contact Lenses

We will try two daily disposable multifocal contact lenses to see which provides better vision and comfort for adults with presbyopia who already wear soft contact lenses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CooperVision International Limited (CVIL) (Industry-sponsored)
• Locations: 1 site (Berkeley, California)
• Trial ID: NCT07444658 on ClinicalTrials.gov

What this trial studies

This is a double-masked, randomized, crossover, 1-week real-world dispensing study in which participants wear two different designs of daily disposable multifocal soft contact lenses for 5–7 days each. Participants are habitual soft contact lens wearers with presbyopia who meet specific refractive and visual acuity criteria. Lens performance will be compared on measures such as distance and near vision and wearer comfort during normal daily activities. The short crossover design allows direct within-person comparison of the two lens materials and designs.

Who should consider this trial

Good fit: Adults aged 18 or older with presbyopia who habitually wear soft contact lenses at least 3 days per week for the past six months, have a reading add of at least +0.75DS, spherical equivalent between +6.00 and -10.00DS, astigmatism no greater than -0.75DC, and distance visual acuity of +0.10 logMAR or better in each eye are ideal candidates.

Not a fit: People with ocular or systemic conditions that contraindicate contact lens wear, those outside the specified refractive or astigmatism ranges, or non-habitual contact lens wearers are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the results could help presbyopic contact lens wearers choose a daily multifocal lens that gives clearer vision and better comfort.

How similar studies have performed: Prior comparative studies of multifocal daily disposable lenses have generally shown that many presbyopes can achieve usable near and distance vision and acceptable comfort, though outcomes vary by lens design and individual.

Eligibility criteria

Inclusion Criteria:

1. They are at least 18 years of age.
2. They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.
3. They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, or sphere 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.
4. They have a minimum reading add of +0.75DS (based on their spectacle refraction)
5. They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye.
6. They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are aphakic.
4. They have had corneal refractive surgery.
5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Where this trial is running

Berkeley, California

• University of California, Berkeley — Berkeley, California, United States (Recruiting)

Study contacts

• Principal investigator: Meng C Lin — University of Berkeley
• Study coordinator: Jose A Vega, OD,MSc,PhD

Conditions Presbyopia