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
This trial does not accept healthy volunteersQualifiers
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 population
Adults aged 40 years or older who currently wear soft multi-focal contact lenses.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
TOTAL30 Multifocal
DeviceTOTAL30 Multifocal
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
16 hours of wear on specified days over a 30-day periodSecondary outcomes
1
Patient-reported vision quality with the TOTAL30 Multifocal Lens
Vision quality assessed using real-time patient-reported data collected at various time points during the day. Patients are asked "What is your impression of the VISION quality of these study lenses?" and provide and answer from -50 (Poor quality) to +50 (Excellent quality) using a sliding digital scale.
Time frame
16 hours of wear on specified days over a 30-day periodOther outcomes
1
Contact Lens Dry Eye Questionnaire (CLDEQ-8)
A series of 8 questions that ask participants to rate eye discomfort, eye dryness, and blurry vision on a frequency scale (0 Never, 1 Rarely, 2 Sometimes, 3 Frequently, 4 Constantly) and an intensity scale (0 Never, 1 not intense to 5 Very Intense). Scores on individual questions are added together to determine a total score. Higher values indicate worse outcomes. The minimum score is 1 and the maximum score is 37.
Time frame
After 1 month of wear2
Distance Visual Acuity
Time frame
After 1 month of wear3
Near Visual Acuity
Time frame
After 1 month of wearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Scripps Poway Eyecare and Optometry
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov