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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOTAL30 Multifocal | Device | TOTAL30 Multifocal |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 hours of wear on specified days over a 30-day period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria:
Exclusion Criteria:
If any of the following exclusion criteria are applicable, the subject should not be enrolled in the study.
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Adults aged 40 years or older who currently wear soft multi-focal contact lenses.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leslie Shan | Contact | 858-530-2800 | lshanod@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jay Mashouf, OD | Scripps Optometric Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Optometric Group | Recruiting | San Diego | California | 92131 | United States |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D011305 | Presbyopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| After 1 month of wear |
| Distance Visual Acuity | After 1 month of wear |
| Near Visual Acuity | After 1 month of wear |