Comfort and Vision With TOTAL30 Multifocal Lenses
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorScripps Poway Eyecare and Optometry
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TOTAL30 Multifocal
Treatment groups
No treatment groups listed
Sponsors and collaborators
Scripps Poway Eyecare and Optometry
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov