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There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A | Active Comparator | Marketed control soft contact lens |
|
| Prototype E1 | Experimental | Investigational soft contact lens |
|
| Prototype E2 | Experimental | Investigational soft contact lens |
|
| Prototype E3 | Experimental | Investigational soft contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACUVUE 2 | Device | worn in a daily wear modality; lenses will be replaced after 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining (Area) | Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. 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). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported. | Baseline and 4-Week Follow-up |
| Corneal Staining (Depth) | Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported. | Baseline and 4-Week Follow-up |
| Corneal Staining (Type) | Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported. | Baseline and 4-Week Follow-up |
| Limbal Conjunctival Redness | Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point. |
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Inclusion Criteria:
The subject must be between 18 and 39 years of age.
The subject must be able to read and understand English.
The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
The subject must require a visual correction in both eyes (no monofit or monovision allowed).
The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chennai | Tamil Nadu | 600 006 | India |
A total of 80 subjects were enrolled in this study. Of the enrolled subjects 4 did not meet the eligibility criteria and 76 were randomized to receive a study lens. Of the randomized subjects 72 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A | Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study. |
| FG001 | Prototype E1 | Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study. |
| FG002 | Prototype E2 | Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study. |
| FG003 | Prototype E3 | Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects that were enrolled into the study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon A | Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study. |
| BG001 | Prototype E1 | Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this 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 | Corneal Staining (Area) | Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. 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). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported. | The analysis population consist of all subjects that completed all study visits without a major protocol. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
Throughout the duration of the study. Approximately 5 months.
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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 | Etafilcon A | Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-significant Ocular Event | Eye disorders | Includes Contact lens Papillary Conjunctivitis, Symptoms or Complaints requiring treatment, Slit lamp findings(Grade 2 or less) requiring treatment and using aosept solution to rinse lens resulting in burning and irritation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tawnya Wilson, Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-1834 | TWilson@ITS.JNJ.com |
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| Prototype E1 |
| Device |
worn in a daily wear modality; lenses will be replaced after 2 weeks |
|
|
| Prototype E2 | Device | worn in a daily wear modality; lenses will be replaced after 2 weeks |
|
|
| Prototype E3 | Device | worn in a daily wear modality; lenses will be replaced after 2 weeks |
|
|
| Baseline and 2-Week Follow-up |
| Bulbar Conjunctival Redness | Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point. | Baseline and 2-Week Follow-up |
| Visual Acuity (LogMAR) | Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported. | 4-Week Follow-up |
| Lens Fitting Characteristics | Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported. | Post Lens Fitting and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Burning/Stinging) | The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Corneal Edema | Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | Baseline and 4-Week Follow-up |
| Conjunctival Injection | Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | Baseline and 4-Week Follow-up |
| Corneal Neovascularization | Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | Baseline and 4-Week Follow-up |
| Corneal Staining | Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | Baseline and 4-Week Follow-up |
| Tarsal Abnormalities | Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported. | 1-, 2- and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Dryness) | The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Lens Awareness) | The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Redness) | The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| Percentage of Reported Ocular Symptoms (Variable Vision) | The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Baseline and 4-Week Follow-up |
| No Longer Meets Eligibility Criteria |
|
| Not comfortable with lens care system |
|
| Unsatisfactory Lens Fitting |
|
| BG002 | Prototype E2 | Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study. |
| BG003 | Prototype E3 | Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study.
| OG001 | Prototype E1 | Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study. |
| OG002 | Prototype E2 | Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study. |
| OG003 | Prototype E3 | Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study. |
|
|
| Primary | Corneal Staining (Depth) | Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported. | The analysis population consist of all subjects that completed all study visits without a major protocol. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Corneal Staining (Type) | Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported. | The analysis population consist of all subjects that completed all study visits without a major protocol. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Limbal Conjunctival Redness | Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2-Week Follow-up | Subject Eye | Subject Eye |
|
|
|
| Primary | Bulbar Conjunctival Redness | Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 2-Week Follow-up | Subject Eye | Subject Eye |
|
|
|
| Primary | Visual Acuity (LogMAR) | Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | LogMAR | 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Lens Fitting Characteristics | Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported. | The analysis population consists of all subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Post Lens Fitting and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Burning/Stinging) | The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Corneal Edema | Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Conjunctival Injection | Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Corneal Neovascularization | Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Corneal Staining | Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported. | All subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Tarsal Abnormalities | Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported. | The analysis population consists of all subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | 1-, 2- and 4-Week Follow-up | Subject Eyes | Subject Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Dryness) | The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Lens Awareness) | The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Redness) | The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| Primary | Percentage of Reported Ocular Symptoms (Variable Vision) | The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up. | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Eyes | Baseline and 4-Week Follow-up | Eyes | Eyes |
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | Prototype E1 | Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study. | 0 | 19 | 1 | 19 |
| EG002 | Prototype E2 | Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study. | 0 | 19 | 4 | 19 |
| EG003 | Prototype E3 | Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study. | 0 | 19 | 4 | 19 |
|
| Low Blood Pressure | Blood and lymphatic system disorders | Not Study Related |
|
| Upset Stomach | Gastrointestinal disorders | Not Study Related |
|
| Muscle Sprain | Musculoskeletal and connective tissue disorders | Not Study Related |
|
| Minimal Skin Bruises | Blood and lymphatic system disorders | Not Study Related |
|
Not provided
| Subject Eyes |
|
| 4-week Follow-up |
|
| Subject Eyes |
|
| 4-week Follow-up |
|
| Subject Eye |
|
| 2-week Follow-up |
|
| Subject Eye |
|
| 2-week Follow-up |
|
| Eyes |
|
| Eyes |
|
| 4-week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Subject Eyes |
|
| 4-week Follow-up |
|
| Subject Eyes |
|
| 4-week Follow-up |
|
| Subject Eyes |
|
| 4-week Follow-up |
|
| Subject Eyes |
|
| 4-week Follow-up |
|
| Subject Eyes |
|
| 2-week Follow-up |
|
| 4-week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|
| Eyes |
|
| 4- Week Follow-up |
|