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Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A
This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.
The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.
Study groups:
Group 1: stenfilcon A vs. narafilcon A
Group 2: stenfilcon A vs. delefilcon A
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stenfilcon A vs narafilcon A (Group 1) | Active Comparator | Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study. |
|
| stenfilcon A vs delefilcon A (Group 2) | Active Comparator | Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stenfilcon A | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Foreign Body Sensation | Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation | 1 week |
| Itching Sensation on Removal | Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation | 1 week |
| Red Eye Sensation | Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation | 1 week |
| Dryness | Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all. | 1 week |
| Comfort | Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Horizontal Centration | Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal) | Baseline |
| Lens Fit - Horizontal Centration |
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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 |
|---|---|---|
| Yuji Kodama, MD, PhD | Director, Kodama Eye Clinic | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stenfilcon A, Then Narafilcon A (Group 1) | Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens narafilcon A: contact lens |
| FG001 | Narafilcon A, Then Stenfilcon A (Group 1) | Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens narafilcon A: contact lens |
| FG002 | Stenfilcon A, Then Delefilcon A (Group 2) | Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens delefilcon A: contact lens |
| FG003 | Delefilcon A, Then Stenfilcon A (Group 2) | Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens delefilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
| |||||||||||||
| Second Intervention (1 Week) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Characteristics - Group 1:Stenfilcon A & Narafilcon A | Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens narafilcon A: contact lens |
| BG001 | Overall Characteristics - Group 2: Stenfilcon A & Delefilcon A |
| 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 | Pain and Foreign Body Sensation | Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation | Posted | Number | eyes | 1 week | Eyes | Eyes |
|
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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 | Stenfilcon A (Group 1) | Participants randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week then cross over. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Professional Service | CooperVision Inc. | +81 3 5449 6619 | Taku.Muraoka@jp.coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.
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| narafilcon A | Device | contact lens |
|
| delefilcon A | Device | contact lens |
|
| Vision | Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision). | 1 week |
| Handling | Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling. | 1 week |
| Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A). | 1 week |
| Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A). | 1 week |
Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal) |
| 1 week |
| Lens Fit - Vertical Centration | Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower) | Baseline |
| Lens Fit - Vertical Centration | Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower) | 1 week |
| Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose) | Baseline |
| Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose) | 1 week |
| Lens Fit Overall | Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear)) | Baseline |
| Lens Fit Overall | Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear)) | 1 week |
| Conjunctival Redness | Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | 1 week |
| Limbal Redness | Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | 1 week |
| Corneal Staining | Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | 1 week |
| Corneal Neovascularization | Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | 1 week |
| Conjunctival Staining | Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | 1 week |
| Corneal Oedema | Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | 1 week |
| Papillary Conjunctivitis | Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | 1 week |
| COMPLETED |
|
| NOT COMPLETED |
|
Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens delefilcon A: contact lens |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A: contact lens
narafilcon A: contact lens
| OG002 | Stenfilcon A (Group 2) | Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens delefilcon A: contact lens |
| OG003 | Delefilcon A (Group 2) | Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study. stenfilcon A: contact lens delefilcon A: contact lens |
|
|
| Primary | Itching Sensation on Removal | Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Primary | Red Eye Sensation | Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Primary | Dryness | Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Comfort | Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort). | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Vision | Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision). | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Handling | Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Primary | Lens Preference - Stenfilcon A/Narafilcon A (Group 1) | Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A). | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Primary | Lens Preference - Stenfilcon A/Delefilcon A (Group 2) | Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A). | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Lens Fit - Horizontal Centration | Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Lens Fit - Horizontal Centration | Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Lens Fit - Vertical Centration | Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Lens Fit - Vertical Centration | Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Lens Fit Overall | Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear)) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Secondary | Lens Fit Overall | Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear)) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Redness | Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Limbal Redness | Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Corneal Staining | Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Corneal Neovascularization | Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Conjunctival Staining | Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Corneal Oedema | Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| Secondary | Papillary Conjunctivitis | Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe) | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Narafilcon A (Group1) | Participants randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week then cross over. | 0 | 55 | 0 | 55 |
| EG002 | Stenfilcon A (Group 2) | Participants randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week then cross over. | 0 | 51 | 0 | 51 |
| EG003 | Delefilcon A (Group 2) | Participants randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week then cross over. | 0 | 51 | 0 | 51 |
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| Eyes |
|
| Slight sensation |
|
| Mild sensation |
|
| Heavy sensation |
|
| Eyes |
|
| Slight sensation |
|
| Mild sensation |
|
| Heavy sensation |
|
| Right before removal |
|
| All day long |
|
| Right before removal |
|
| All day long |
|
| Right before removal |
|
| All day long |
|
| Lens removal |
|
| Eyes |
|
| Little Temporal |
|
| Central |
|
| Little Nasal |
|
| Nasal |
|
| Eyes |
|
| Little Temporal |
|
| Central |
|
| Little Nasal |
|
| Nasal |
|
| Eyes |
|
| Little Upper |
|
| Central |
|
| Little Lower |
|
| Lower |
|
| Eyes |
|
| Little Upper |
|
| Central |
|
| Little Lower |
|
| Lower |
|
| Eyes |
|
| Little Tight |
|
| Optimum |
|
| Little Loose |
|
| Loose |
|
| Eyes |
|
| Little Tight |
|
| Optimum |
|
| Little Loose |
|
| Loose |
|
| Eyes |
|
| Good |
|
| Acceptable |
|
| Not Acceptable |
|
| Eyes |
|
| Good |
|
| Acceptable |
|
| Not Acceptable |
|
| Eyes |
|
| Trace |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Eyes |
|
| Trace |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Eyes |
|
| Trace |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Eyes |
|
| Trace |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Eyes |
|
| Trace |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Eyes |
|
| Trace |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Eyes |
|
| Trace |
|
| Mild |
|
| Moderate |
|
| Severe |
|