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Comfort and Vision With TOTAL30 Multifocal Lenses

NCT07284966 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2026-02-09

No results posted yet for this study

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

Interventions

DEVICE

TOTAL30 Multifocal

TOTAL30 Multifocal

Sponsors & Collaborators

  • Sengi

    collaborator INDUSTRY

  • Scripps Poway Eyecare and Optometry

    lead OTHER

Principal Investigators

  • Jay Mashouf, OD · Scripps Optometric Group

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2027-01-21
Completion
2027-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284966 on ClinicalTrials.gov