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The purpose of this study is to validate the clinical performance of a new contact lens design.
Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test lens | Active Comparator | Subjects randomized to wear pair of test lens either first or second |
|
| stenfilcon A lens (control) | Active Comparator | Subjects randomized to wear pair of control lens either first or second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phoebe test lens | Device | Daily disposable contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining Extent | Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area). | Baseline |
| Corneal Staining Extent | Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area). | Day 3 |
| Conjunctival Staining Score | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps | Baseline |
| Conjunctival Staining Score | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps | Day 3 |
| Palpebral Hyperemia on Upper Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | Baseline |
| Palpebral Hyperemia on Upper Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | Day 3 |
| Palpebral Hyperemia on Lower Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity | Distance visual acuity recorded in logMAR. | Baseline (at lens dispense) |
| Distance Visual Acuity | Distance visual acuity recorded in logMAR. |
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Inclusion criteria
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Kolbaum, O.D., Ph.D., FAAO, FBCLA | Clinical Optics Research Lab (CORL), Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optical Research Lab (CORL) | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens, Then Control Lens | Subjects randomized to wear pair of test lens, then control lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens |
| FG001 | Control Lens, Then Test Lens | Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
There were six (6) protocol deviations and data was not included in the analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects randomized to wear pair of test/control lens either first or second, then wear other lens. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable 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 | Corneal Staining Extent | Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area). | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
From dispense up to three days for each intervention.
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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 Lens | Subjects were randomized to wear pair of test lens for 3 days. Phoebe test lens: Daily disposable contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen, OD, Manager of Clinical Research | CooperVision | 19257306716 | MNguyen@coopervision.com |
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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 | Sep 28, 2017 | May 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Double masked (participant, investigator)
| stenfilcon A lens (control) | Device | Daily disposable contact lens |
|
|
| Baseline |
| Palpebral Hyperemia on Lower Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | Day 3 |
| Palpebral Roughness Grade - Upper Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Baseline |
| Palpebral Roughness Grade - Upper Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Day 3 |
| Palpebral Roughness Grade - Lower Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Baseline |
| Palpebral Roughness Grade - Lower Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Day 3 |
| Day 3 |
| Near Visual Acuity | Near visual acuity recorded in logMAR | Baseline (at dispense) |
| Near Visual Acuity | Near visual acuity recorded in logMAR | Day 3 |
| Vision Quality Rating | Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent) | Baseline (at dispense) |
| Vision Quality Rating | Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent) | Day 3 |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 |
|
| Stenfilcon A Control Lens |
Subjects randomized to wear pair of control lens, then test lens. Each lens type was worn for three days using a daily wear / daily replacement schedule. Phoebe test lens: Daily disposable contact lens stenfilcon A lens (control): Daily disposable contact lens |
|
|
| Primary | Corneal Staining Extent | Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area). | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Day 3 | Eyes | Eyes |
|
|
|
| Primary | Conjunctival Staining Score | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | score on a scale | Baseline | Eyes | Eyes |
|
|
|
| Primary | Conjunctival Staining Score | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | score on a scale | Day 3 | Eyes | Eyes |
|
|
|
| Primary | Palpebral Hyperemia on Upper Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Primary | Palpebral Hyperemia on Upper Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Day 3 | Eyes | Eyes |
|
|
|
| Primary | Palpebral Hyperemia on Lower Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Primary | Palpebral Hyperemia on Lower Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Day 3 | Eyes | Eyes |
|
|
|
| Primary | Palpebral Roughness Grade - Upper Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Primary | Palpebral Roughness Grade - Upper Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Day 3 | Eyes | Eyes |
|
|
|
| Primary | Palpebral Roughness Grade - Lower Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline | Eyes | Eyes |
|
|
|
| Primary | Palpebral Roughness Grade - Lower Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Day 3 | Eyes | Eyes |
|
|
|
| Secondary | Distance Visual Acuity | Distance visual acuity recorded in logMAR. | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | Log(MAR) | Baseline (at lens dispense) |
|
|
|
| Secondary | Distance Visual Acuity | Distance visual acuity recorded in logMAR. | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | Log(MAR) | Day 3 |
|
|
|
| Secondary | Near Visual Acuity | Near visual acuity recorded in logMAR | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | Log(MAR) | Baseline (at dispense) |
|
|
|
| Secondary | Near Visual Acuity | Near visual acuity recorded in logMAR | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | Log(MAR) | Day 3 |
|
|
|
| Secondary | Vision Quality Rating | Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent) | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Baseline (at dispense) |
|
|
|
| Secondary | Vision Quality Rating | Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent) | There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses. | Posted | Mean | Standard Deviation | units on a scale | Day 3 |
|
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Stenfilcon A Lens (Control) | Subjects were randomized to wear pair of control lens for 3 days. stenfilcon A lens (control): Daily disposable contact lens | 0 | 53 | 0 | 53 | 0 | 53 |
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