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Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study.
Three-month, open-label, bilateral, parallel group, randomized, daily wear contact lens dispensing study comparing the Qualis Silicone Hydrogel Soft Contact Lens for Daily Wear with the currently marketed Acuvue Vita (senofilcon C) Monthly Contact Lens (FDA cleared under K160212). Eligible subjects will be examined for baseline evaluation and lens fitting. Up to fifty (50) subjects will wear the test contact lenses and up to twenty-five (25) subjects will wear the control contact lenses. The subjects will undergo standard ophthalmic evaluation for contact lens wear and will be followed for a period of at least ninety (91) days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Experimental | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. |
|
| Control Device: Acuvue Vita Monthly Contact Lens | Active Comparator | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft (hydrophilic) contact lens | Device | The intervention is a daily wear soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Non-Serious Adverse Reactions | The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations. | 91 days |
| Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better | 91 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects may not be enrolled into the study if ANY of the following apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ala Moana Advanced Eye Clinic | Honolulu | Hawaii | 96814 | United States | ||
| SUNY College of Optometry |
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The enrollment period started in July 2020 and was closed in October 2020 after successfully fulfilling the enrollment goal (75 subjects). Data collection occurred from July 22, 2020 to January 28, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens |
| FG001 | Control Device: Acuvue Vita Monthly Contact Lens | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Eyes With Non-Serious Adverse Reactions | The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations. | open-label, multi-center, randomized concurrent-control study with the treatment duration of 91 days. Seventy-five (75) subjects were enrolled in the study-of which 50 subjects wore the test lenses (Qualis (Linofilcon A) Silicone Hydrogel Soft Contact Lens for Daily Wear) and 25 subjects wore the control lenses (Acuvue Vita (senofilcon C) Monthly Contact Lens). | Posted | Number | eyes | 91 days | eyes | eyes |
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through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91.
Through study completion, every visit, Day7,Day 14,Day 30, Day 60 and Day 91. by regular investigator assessment. In general, an 'adverse event' refers to any undesirable clinical occurrence in a subject, whether it is considered to be device-related or not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Device: Qualis Silicone Hydrogel Soft Contact Lens | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Test Device is investigational and not cleared/approved by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | General disorders | Systematic Assessment | Common cold - not COVID-19; confirmed by PCR testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jimmy Chou | Unicon Optical Co., Ltd. | +88635775586 | 1307 | ra@uniconvision.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2020 | May 10, 2023 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 14, 2020 | Apr 14, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| New York |
| New York |
| 10036 |
| United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| BG001 | Control Device: Acuvue Vita Monthly Contact Lens | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control Device: Acuvue Vita Monthly Contact Lens | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens |
|
|
| Primary | Number of Eyes With Best-corrected Contact Lens Visual Acuity of +0.10 logMAR or Better | The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of +0.10 logMAR or better | Posted | Number | eyes | 91 days | eyes | eyes |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 6 |
| 50 |
| EG001 | Control Device: Acuvue Vita Monthly Contact Lens | Test lenses will be worn on a daily wear basis for up to one month with removal for cleaning, disinfection, and storage prior to sleeping. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week. The Control Device is cleared by the US FDA. soft (hydrophilic) contact lens: The intervention is a daily wear soft contact lens | 0 | 25 | 0 | 25 | 3 | 25 |
|
| Migraines | General disorders | Systematic Assessment | Migraines |
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| Covid-19 positive | General disorders | Systematic Assessment | Covid-19 positive. |
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| Presceptal Cellulitis | Eye disorders | Systematic Assessment | Presceptal Cellulitis, right eye |
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| Internal hordeolum | Eye disorders | Systematic Assessment | Internal hordeolum, right eye |
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| Visual aura | Eye disorders | Systematic Assessment | Visual aura associated with migraine headaches. OU |
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| papillary conjunctivitis | Eye disorders | Systematic Assessment | papillary conjunctivitis, right eye |
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| Mild contact dermatitis | Eye disorders | Systematic Assessment | Mild contact dermatitis, OU |
|
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