Comfort and Vision With TOTAL30 Multifocal Lenses

NCT07284966 | Recruiting FDA Device

• 1 other identifier: JM-25-02
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, prospective, observational study conducted at one site to evaluate the comfort and vision of the TOTAL30 Multifocal (T30MF) contact lenses over the course of long wear days. The study will assess the proportion of positive subjective Visual Analog Scale (VAS) assessments of comfort and vision at 10, 12, 14, and 16 hours of wear on Days 1, 7, 14, and 30. Additionally, the study will explore subjective assessments of lens comfort using the CLDEQ-8 survey and measure logMAR visual acuity at both distance and near at Visit 1, Visit 2, and after 1 month of lens wear. Participants will undergo three site visits, with at-home surveys conducted at specified intervals to gather real-time data on comfort and vision.

Conditions

Myopia; Presbyopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Patient-reported comfort level of the TOTAL30 Multifocal Lens

  Comfort level assessed using real-time patient-reported data collected at multiple time points throughout the day, with a focus on the end of the wear period. Patients are asked "What is your impression of the COMFORT of these study lenses?" and provide and answer from -50 (Extremely uncomfortable) to +50 (Extremely comfortable) using a sliding digital scale.

  16 hours of wear on specified days over a 30-day period

Secondary Outcomes (1)

• Patient-reported vision quality with the TOTAL30 Multifocal Lens

  16 hours of wear on specified days over a 30-day period

Other Outcomes (3)

• Contact Lens Dry Eye Questionnaire (CLDEQ-8)

  After 1 month of wear

• Distance Visual Acuity

  After 1 month of wear

• Near Visual Acuity

  After 1 month of wear

Interventions

TOTAL30 Multifocal DEVICE

TOTAL30 Multifocal

Eligibility Criteria

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

Study Population

Adults aged 40 years or older who currently wear soft multi-focal contact lenses.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scripps Poway Eyecare and Optometry: lead
• Sengi: collaborator

Study Sites (1)

Scripps Optometric Group

San Diego, California, 92131, United States

RECRUITING

MeSH Terms

Conditions

Myopia; Presbyopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Jay Mashouf, OD

  Scripps Optometric Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Shan

CONTACT

858-530-2800; lshanod@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 16, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): January 21, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)