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This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator | Other | Subjects that are between the ages 18-55 and are current spherical soft contact lens wearers will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A contact lenses | Device | Senofilcon A Daily Disposable Contact Lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Meibomian Gland Imaging | Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%. | 4-Week Follow-up |
| Meibomian Gland Expressibility | Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian Gland Secretion Score was calculated by adding the grades for the 15 glands assessed. Mean and standard deviation for total grade per region and total Meibomian Gland Secretion Score were reported for each stratum. Total scores range from 0 to 15 were lower score indicate worsening meibomian gland expressability. | 4-Week Follow-up |
| Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings | Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal:
The number of positive findings (yes) was reported for each group. | 4-Week Follow-up |
| Lid Wiper Epitheliopathy | Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades indicate worsening lid wiper epitheliopathy. |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Redness | Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe. | 4-Week Follow-up |
| Conjunctival Staining |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 18 and 55 (inclusive) years of age at the time of screening.
Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week wear time over the last 1 month by self-report.
Have a baseline CLDEQ-8 score of either:
Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
Subjects must pass a pre-screening questionnaire.
Subjects must be willing to discontinue all contact lens wear for approximately 1 week/
Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRC-East | Jacksonville | Florida | 32256 | United States | ||
| University of Waterloo Center for Contact Lens Research |
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Subjects were stratified into two subject groups: symptomatic (baseline CLDEQ-8 score of 15 or greater) and asymptomatic (baseline CLDEQ-8 score of 7 or lower).
A total of 105 subjects were enrolled into this study. Of those enrolled 81, were dispensed a study lens while 24 subjects failed to meet all eligibility criteria. Of those dispensed a study lens, 73 completed the study while 8 subjects were discontinued. All subjects were disepsned the same study lens senofilcon A.
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| ID | Title | Description |
|---|---|---|
| FG000 | Asymptomatic | Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration. |
| FG001 | Symptomatic | Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asymptomatic | Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study |
| BG001 | Symptomatic | Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study. |
| 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 | Meibomian Gland Imaging | Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%. | All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock. | Posted | Number | eyes | 4-Week Follow-up | Eyes | Eyes |
|
Throughout the entire duration of the study. Approximately 5 weeks per subject.
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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 | Senofilcon A | All subjects that wore the senofilcon A lens at any point throughout the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Dow, OD, FAAO - Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. | 904-443-1061 | edow1@its.jnj.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 | Oct 3, 2017 | Aug 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| 4-Week Follow-up |
| Conjunctival Folds | Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm). | 4-Week Follow-up |
Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining). |
| 4-Week Follow-up |
| Corneal Staining | Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (>1mm). Corneal staining area was evaluated using the following the scale: Grade 0 = 0% of region covered, Grade 1 = 10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4 = 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered, Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered, and Grade 10 = 100% of region covered. The following scale was used in the grading of corneal staining depth: Grade 0 = None, Grade 0 = Superficial epithelial, Grade 2 = Full epithelial, and Grade 3 = Stromal glow. | 4-Week Follow-up |
| Tear Film Lipid Layer Thickness | Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm. | 4-Week Follow-up |
| Tear Film Stability | Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. Three measurements were taken on each eye. The average NIBUT was reported for each group. | 4-Week Follow-up |
| Tear Film Lipid Pattern | Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other. | 4-Week Follow-up |
| Waterloo |
| Ontario |
| Canada |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Symptomatic |
Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study |
|
|
| Primary | Meibomian Gland Expressibility | Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian Gland Secretion Score was calculated by adding the grades for the 15 glands assessed. Mean and standard deviation for total grade per region and total Meibomian Gland Secretion Score were reported for each stratum. Total scores range from 0 to 15 were lower score indicate worsening meibomian gland expressability. | All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock. | Posted | Mean | Standard Deviation | Score on a Scale | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings | Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal:
The number of positive findings (yes) was reported for each group. | All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock. | Posted | Number | Number of eyes | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Lid Wiper Epitheliopathy | Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades indicate worsening lid wiper epitheliopathy. | All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock. | Posted | Mean | Standard Deviation | Units on a scale | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Conjunctival Folds | Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm). | All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock. | Posted | Number | eyes | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Redness | Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe. | All subjects dispensed a study lens. | Posted | Number | eyes | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Staining | Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining). | All subjects dispensed a study lens. | Posted | Number | eyes | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Secondary | Corneal Staining | Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (>1mm). Corneal staining area was evaluated using the following the scale: Grade 0 = 0% of region covered, Grade 1 = 10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4 = 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered, Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered, and Grade 10 = 100% of region covered. The following scale was used in the grading of corneal staining depth: Grade 0 = None, Grade 0 = Superficial epithelial, Grade 2 = Full epithelial, and Grade 3 = Stromal glow. | All subjects dispensed a study lens. | Posted | Number | eyes | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Secondary | Tear Film Lipid Layer Thickness | Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm. | All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock. | Posted | Mean | Standard Deviation | nm | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Secondary | Tear Film Stability | Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. Three measurements were taken on each eye. The average NIBUT was reported for each group. | All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock. | Posted | Mean | Standard Deviation | seconds | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Secondary | Tear Film Lipid Pattern | Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other. | All subjects that completed all study visits without a major protocol deviation. | Posted | Number | eyes | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
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| Nasal Lower Lid |
|
| Total Score |
|
| Meibomian Gland Pouting, Plugging, or Capping |
|
| Lid/Lash Margin Debris Findings |
|
| Temporal- Grade 2 |
|
| Temporal- Grade 3 |
|
| Nasal- Grade 0 |
|
| Nasal- Grade 1 |
|
| Nasal- Grade 2 |
|
| Nasal- Grade 3 |
|
| Bulbar-Nasal- Grade 2 |
|
| Bulbar-Nasal- Grade 3 |
|
| Bulbar-Nasal- Grade 4 |
|
| Bulbar-Temporal- Grade 0 |
|
| Bulbar-Temporal- Grade 1 |
|
| Bulbar-Temporal- Grade 2 |
|
| Bulbar-Temporal- Grade 3 |
|
| Bulbar-Temporal- Grade 4 |
|
| Bulbar-Inferior-Grade 0 |
|
| Bulbar-Inferior-Grade 1 |
|
| Bulbar-Inferior-Grade 2 |
|
| Bulbar-Inferior-Grade 3 |
|
| Bulbar-Inferior-Grade 4 |
|
| Bulbar-Superior- Grade 0 |
|
| Bulbar-Superior- Grade 1 |
|
| Bulbar-Superior- Grade 2 |
|
| Bulbar-Superior- Grade 3 |
|
| Bulbar-Superior- Grade 4 |
|
| Limbal-Nasal- Grade 0 |
|
| Limbal-Nasal- Grade 1 |
|
| Limbal-Nasal- Grade 2 |
|
| Limbal-Nasal- Grade 3 |
|
| Limbal-Nasal- Grade 4 |
|
| Limbal-Temporal- Grade 0 |
|
| Limbal-Temporal- Grade 1 |
|
| Limbal-Temporal- Grade 2 |
|
| Limbal-Temporal- Grade 3 |
|
| Limbal-Temporal- Grade 4 |
|
| Limbal-Inferior- Grade 0 |
|
| Limbal-Inferior- Grade 1 |
|
| Limbal-Inferior- Grade 2 |
|
| Limbal-Inferior- Grade 3 |
|
| Limbal-Inferior- Grade 4 |
|
| Limbal-Superior- Grade 0 |
|
| Limbal-Superior- Grade 1 |
|
| Limbal-Superior- Grade 2 |
|
| Limbal-Superior- Grade 3 |
|
| Limbal-Superior- Grade 4 |
|
| Nasal- Grade 2 |
|
| Nasal- Grade 3 |
|
| Temporal- Grade 0 |
|
| Temporal- Grade 1 |
|
| Temporal- Grade 2 |
|
| Temporal- Grade 3 |
|
| Inferior-Grade 0 |
|
| Inferior-Grade 1 |
|
| Inferior-Grade 2 |
|
| Inferior-Grade 3 |
|
| Superior- Grade 0 |
|
| Superior- Grade 1 |
|
| Superior- Grade 2 |
|
| Superior- Grade 3 |
|
| Staining Type- Central- Grade 2 |
|
| Staining Type- Central- Grade 3 |
|
| Staining Type-Inferior - Grade 0 |
|
| Staining Type-Inferior - Grade 1 |
|
| Staining Type-Inferior - Grade 2 |
|
| Staining Type-Inferior - Grade 3 |
|
| Staining Type-Nasal - Grade 0 |
|
| Staining Type-Nasal - Grade 1 |
|
| Staining Type-Nasal - Grade 2 |
|
| Staining Type-Nasal - Grade 3 |
|
| Staining Type-Temporal-Grade 0 |
|
| Staining Type-Temporal-Grade 1 |
|
| Staining Type-Temporal-Grade 2 |
|
| Staining Type-Temporal-Grade 3 |
|
| Staining Type- Superior- Grade 0 |
|
| Staining Type- Superior- Grade 1 |
|
| Staining Type- Superior- Grade 2 |
|
| Staining Type- Superior- Grade 3 |
|
| Staining- Area- Central- Grade 0 |
|
| Staining- Area- Central- Grade 1 |
|
| Staining- Area- Central- Grade 2 |
|
| Staining- Area- Central- Grade 3 |
|
| Staining- Area- Central- Grade 4 |
|
| Staining- Area- Central- Grade 5 |
|
| Staining- Area- Central- Grade 6 |
|
| Staining- Area- Inferior- Grade 0 |
|
| Staining- Area- Inferior- Grade 1 |
|
| Staining- Area- Inferior- Grade 2 |
|
| Staining- Area- Inferior- Grade 3 |
|
| Staining- Area- Inferior- Grade 4 |
|
| Staining- Area- Inferior- Grade 5 |
|
| Staining- Area- Inferior- Grade 6 |
|
| Staining- Area-Nasal-Grade 0 |
|
| Staining- Area-Nasal-Grade 1 |
|
| Staining- Area-Nasal-Grade 2 |
|
| Staining- Area-Nasal-Grade 3 |
|
| Staining- Area-Nasal-Grade 4 |
|
| Staining- Area-Nasal-Grade 5 |
|
| Staining- Area-Nasal-Grade 6 |
|
| Staining-Area-Temporal-Grade 0 |
|
| Staining-Area-Temporal-Grade 1 |
|
| Staining-Area-Temporal-Grade 2 |
|
| Staining-Area-Temporal-Grade 3 |
|
| Staining-Area-Temporal-Grade 4 |
|
| Staining-Area-Temporal-Grade 5 |
|
| Staining-Area-Temporal-Grade 6 |
|
| Staining-Area-Superior-Grade 0 |
|
| Staining-Area-Superior-Grade 1 |
|
| Staining-Area-Superior-Grade 2 |
|
| Staining-Area-Superior-Grade 3 |
|
| Staining-Area-Superior-Grade 4 |
|
| Staining-Area-Superior-Grade 5 |
|
| Staining-Area-Superior-Grade 6 |
|
| Staining-Depth-Central-Grade 0 |
|
| Staining-Depth-Central-Grade 1 |
|
| Staining-Depth-Central-Grade 2 |
|
| Staining-Depth-Inferior-Grade 0 |
|
| Staining-Depth-Inferior-Grade 1 |
|
| Staining-Depth-Inferior-Grade 2 |
|
| Staining-Depth-Nasal-Grade 0 |
|
| Staining-Depth-Nasal-Grade 1 |
|
| Staining-Depth-Nasal-Grade 2 |
|
| Staining-Depth-Temporal-Grade 0 |
|
| Staining-Depth-Temporal-Grade 1 |
|
| Staining-Depth-Temporal-Grade 2 |
|
| Staining-Depth-Superior-Grade 0 |
|
| Staining-Depth-Superior-Grade 1 |
|
| Staining-Depth-Superior-Grade 2 |
|
| Closed (Tight) |
|
| Flow (Wave) |
|
| Amorphous |
|
| Colors |
|
| Others |
|