Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.
The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A 1 day test lens | Experimental | Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. |
|
| somofilcon A 1 day control lens | Active Comparator | Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A 1 day test lens | Device | Contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever) | up to 1 week |
| Preference | Overall lens that subject prefers or no preference | up to 1 week |
| Vision | Visual acuity measured in logMAR | Up to 1 week |
| Subjective Vision | Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time) | up to 1 week |
| Corneal Staining | Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps | up to 1 week |
| Conjunctival Staining | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps | up to 1 week |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Three (3) subjects did not meet inclusion criteria and were excluded from the analysis. One subject was enrolled and later discontinued.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Somofilcon A 1 Day Test Lens First, Then Control 1 Day Lens | Subjects wear the somofilcon A 1 day Test Lens first for one week, then somofilcon A 1 day Control lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens |
| FG001 | Somofilcon A 1 Day Control Lens First, Then 1 Day Test Lens | Subjects wear the somofilcon A 1 day Control lens first for one week, then somofilcon A 1 day Test lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
|
| ||||||||||||||||||
| Second Intervention (1 Week) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Somofilcon A 1 Day Test vs Control Contact Lens | Each subjects randomized to wear either the test or control as a matched pair and cross over to second matched pair. somofilcon A 1 day test lens: Test / Contact lens somofilcon A 1 day control lens: Test / Contact lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Comfort | Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever) | Posted | Mean | Standard Deviation | score on a scale | up to 1 week |
|
From dispense to completion of follow up, up to 2 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somofilcon A 1 Day Test Lens | Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen, Sr. Optometrist | Coopervision | 925-730-6716 | mnguyen@coopervision.com |
Not provided
| 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 | Sep 20, 2017 | Jul 9, 2019 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Not provided
Not provided
Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.
| somofilcon A 1 day control lens | Device | Contact lens |
|
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Preference | Overall lens that subject prefers or no preference | Posted | Count of Participants | Participants | up to 1 week |
|
|
|
| Primary | Vision | Visual acuity measured in logMAR | Dispensing - n=32 participants total, 1 week = 31 participants total due to a nonserious adverse events for somofilcon A 1 day test lens. | Posted | Mean | Standard Deviation | Log(MAR) | Up to 1 week |
|
|
|
| Primary | Subjective Vision | Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time) | Posted | Mean | Standard Deviation | score on a scale | up to 1 week |
|
|
|
| Primary | Corneal Staining | Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps | Baseline n=32 participants / 64 eyes, 1 week n = 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed. | Posted | Mean | Standard Deviation | score on a scale | up to 1 week | Eye | Eye |
|
|
|
| Primary | Conjunctival Staining | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps | Baseline n=32 participants / 64 eyes, 1 week n= 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed. | Posted | Mean | Standard Deviation | score on a scale | up to 1 week | Eyes | Eyes |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Somofilcon A 1 Day Control Lens | Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens | 0 | 32 | 0 | 32 | 0 | 32 |
Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
| Title | Measurements |
|---|
|
| Slightly preferred somofilcon A 1 Day Control lens |
|
| Strongly preferred somofilcon A 1 Day control lens |
|
| High Illumination high contrast binocular |
|
| Low Illumination high contrast monocular |
|
| Low Illumination high contrast binocular |
|
|
| 1 week |
|
|
|
| 1 week |
|
|