TOTAL30 multifocal contact lenses: comfort and vision during long wear

Evaluation of Wear Comfort and Vision With Total 30 Multifocal Lenses Over 16 Hours of Wear

This test checks whether TOTAL30 multifocal contact lenses keep vision clear and feel comfortable during long days for people over 40 who already wear soft multifocal contacts.

Quick facts

• Study type: Observational
• Enrollment: 36 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Scripps Poway Eyecare and Optometry (Academic / other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT07284966 on ClinicalTrials.gov

What this trial studies

This is a single-arm, prospective observational study at one site that follows existing soft multifocal contact lens wearers over one month. Participants will attend three clinic visits and complete timed at-home surveys on Days 1, 7, 14, and 30 to record comfort and vision at 10, 12, 14, and 16 hours of wear. Clinic visits include CLDEQ-8 symptom questionnaires and measurement of logMAR visual acuity at distance and near at baseline, an interim visit, and after one month of TOTAL30 Multifocal lens wear. The study collects real-world, long-day wear data using smartphone push notifications to capture prompt, timed responses.

Who should consider this trial

Good fit: Ideal candidates are age 40 or older who already wear soft multifocal contact lenses, can be fit into the TOTAL30 MF parameters, can achieve 20/25 vision in each eye, and are willing to wear lenses long hours and complete smartphone surveys.

Not a fit: Patients under 40, those who cannot be fit into the lens prescription range, those with significant ocular surface disease or high CLDEQ-8 symptom scores, or those unwilling to wear lenses for long hours or complete timed surveys are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, patients may experience multifocal lenses that provide clearer near and distance vision with comfortable long-day wear.

How similar studies have performed: Previous studies of multifocal daily disposable lenses have generally improved near and distance vision for presbyopia, though direct data on comfort during 16-hour long days is more limited.

Eligibility criteria

Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

* Subjects who currently wear soft multi-focal contact lenses and score \<12 on an entering CLDEQ-8 survey.
* Subjects who are \>= 40 years old.
* Subjects who can and are willing to wear their lenses for 13 hours per day during the study period, and 16 hours per day when questionnaires are being taken.
* Willing to insert their contact lenses between 6:00 am and 8:00 am on the days when questionnaires will be taken.
* Vision correctable in soft multi-focal contact lenses to 20/25 (0.10 log MAR) or better in each eye at 6M.
* Must be able to be successfully fit into the prescription parameters available for Total30 MF contact lenses.
* Required to have a smartphone and receive push notifications.
* Willing to attend all study visits.
* Willing to be diligent about answering the timed surveys in a prompt manner.

Exclusion Criteria:

If any of the following exclusion criteria are applicable, the subject should not be enrolled in the study.

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator.
* Use of isotretinoin-derivatives.
* Use of lubricating drops.
* Monocular patients or patients fit with only 1 multifocal lens.
* Prior refractive surgery.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Pregnant or lactating.
* Having participated in a clinical trial in the past 30 days.
* High-ADD habitual wearers using a different fitting approach than Alcon's multifocal fitting guide (e.g., J\&J or CooperVision's fitting guide adopting a modified monovision approach).
* Are past rigid CL wearers.
* Have a history of being diagnosed with dry eye or ocular allergies.
* Have history of severe ocular trauma.

Where this trial is running

San Diego, California

• Scripps Optometric Group — San Diego, California, United States (Recruiting)

Study contacts

• Principal investigator: Jay Mashouf, OD — Scripps Optometric Group
• Study coordinator: Leslie Shan

Conditions Myopia; Presbyopia; Astigmatism