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| Name | Class |
|---|---|
| Foresight Regulatory Strategies, Inc. | INDUSTRY |
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The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 - SiHyDD to Moist | Active Comparator | 1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. |
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| A2 - Moist to SiHyDD | Active Comparator | 1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. |
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| A3 - SiHyDD to OASDD | Active Comparator | 1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses. |
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| A4 - OASDD to SiHyDD | Active Comparator | 1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. |
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| A5 - SiHyDD to DT1 | Active Comparator | 1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase A - olifilcon B with Tangible Coatings | Device | Daily disposable silicone hydrogel contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Lens Preference | Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference. | Visit 3 - Approximately 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score | Difference in CLDEQ-8 score with treatments relative to score with habitual lenses. The scale on the 8-item CLDEQ-8 instrument is from 1 to 33, with each item having a possible 4 or 5 points. | Visit 2 and 3 - Approximately 1 and 2 weeks, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin L Chalmers, OD | Clinical Trial Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ross Eyecare | Atlanta | Georgia | 30324 | United States | ||
| Professional Eye Care Center |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 4, 2021 | |
| Unrelease | Oct 5, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 4, 2021 | Oct 5, 2021 | |||
| Oct 5, 2021 |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Randomized cross-over after 1 week of wear of two lens brands.
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Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
| A6 - DT1 to SiHyDD | Active Comparator | 1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. |
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| B1 - HydDD to Moist | Active Comparator | 1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. |
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| B2 - Moist to HydDD | Active Comparator | 1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses. |
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| B3 - HydDD to BioTrue | Active Comparator | 1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses. |
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| B4 - BioTrue to HydDD | Active Comparator | 1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. |
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| B5 - HydDD to AqCom+ | Active Comparator | 1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses. |
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| B6 - AqCom+ to HydDD | Active Comparator | 1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. |
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| Phase B - etafilcon A with Tangible Coatings | Device | Daily disposable hydrogel contact lens |
|
| Niles |
| Illinois |
| 60714 |
| United States |
| RevolutionEyes | Carmel | Indiana | 46032 | United States |
| Andover Optometry on Central | Andover | Massachusetts | 01810 | United States |
| Professional VisionCare | Westerville | Ohio | 43081 | United States |
| Primary Eyecare Group, PC | Brentwood | Tennessee | 37027 | United States |
| Nov 4, 2021 |
| 4 |