Visual Correction
Conditions
Brief summary
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.
Interventions
DEVICEACUVUE 2
worn in a daily wear modality; lenses will be replaced after 2 weeks
DEVICEPrototype E1
worn in a daily wear modality; lenses will be replaced after 2 weeks
DEVICEPrototype E2
worn in a daily wear modality; lenses will be replaced after 2 weeks
DEVICEPrototype E3
worn in a daily wear modality; lenses will be replaced after 2 weeks
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must be between 18 and 39 years of age. 2. The subject must be able to read and understand English. 3. The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form. 4. The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days. 5. 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). 6. The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol. 7. 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. 8. The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes. 9. The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye. 10. The subject must require a visual correction in both eyes (no monofit or monovision allowed). 11. 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: * No amblyopia * No evidence of lid abnormality or infection (including blepharitis/meibomitis) * No conjunctival abnormality or infection. * No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities). * No other active ocular diseases.
Exclusion criteria
1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 2. Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear. 3. Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. Any ocular infection. 5. Any corneal distortion resulting from previous hard or rigid permeable contact lens wear. 6. Pregnancy or lactation (subjects who become pregnant during the study will be discontinued). 7. No extended wear in the last 3 months. 8. Diabetes. 9. Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV). 10. Has had refractive surgery. 11. Employee of VRF with direct involvement in the study or a family member of the clinic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Staining (Area) | Baseline and 4-Week Follow-up | 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. |
| Corneal Staining (Depth) | Baseline and 4-Week Follow-up | 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. |
| Corneal Staining (Type) | Baseline and 4-Week Follow-up | 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. |
| Limbal Conjunctival Redness | Baseline and 2-Week Follow-up | 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. |
| Bulbar Conjunctival Redness | Baseline and 2-Week Follow-up | 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. |
| Visual Acuity (LogMAR) | 4-Week Follow-up | Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported. |
| Lens Fitting Characteristics | Post Lens Fitting and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Burning/Stinging) | Baseline and 4-Week Follow-up | 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. |
| Corneal Edema | Baseline and 4-Week Follow-up | 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. |
| Conjunctival Injection | Baseline and 4-Week Follow-up | 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. |
| Corneal Neovascularization | Baseline and 4-Week Follow-up | 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. |
| Corneal Staining | Baseline and 4-Week Follow-up | 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. |
| Tarsal Abnormalities | 1-, 2- and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | Baseline and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Dryness) | Baseline and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | Baseline and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | Baseline and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | Baseline and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Lens Awareness) | Baseline and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Redness) | Baseline and 4-Week Follow-up | 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. |
| Percentage of Reported Ocular Symptoms (Variable Vision) | Baseline and 4-Week Follow-up | 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. |
Countries
India
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Etafilcon A Subjects that were randomized to receive etafilcon A contact lens throughout the course of this study. | 19 |
| Prototype E1 Subjects that were randomized to receive Prototype E1 contact lens throughout the course of this study. | 19 |
| Prototype E2 Subjects that were randomized to receive Prototype E2 contact lens throughout the course of this study. | 19 |
| Prototype E3 Subjects that were randomized to receive Prototype E3 contact lens throughout the course of this study. | 19 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | No Longer Meets Eligibility Criteria | 0 | 0 | 1 | 0 |
| Overall Study | Not comfortable with lens care system | 1 | 0 | 0 | 0 |
| Overall Study | Unsatisfactory Lens Fitting | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Etafilcon A | Prototype E1 | Prototype E2 | Prototype E3 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 23.42 years STANDARD_DEVIATION 4.611 | 24.58 years STANDARD_DEVIATION 4.706 | 23.16 years STANDARD_DEVIATION 5.336 | 20.84 years STANDARD_DEVIATION 2.192 | 23.0 years STANDARD_DEVIATION 4.211 |
| Race/Ethnicity, Customized Asian Indian | 19 participants | 19 participants | 19 participants | 19 participants | 76 participants |
| Region of Enrollment India | 19 participants | 19 participants | 19 participants | 19 participants | 76 participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 11 Participants | 11 Participants | 48 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 8 Participants | 8 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 19 | 1 / 19 | 4 / 19 | 4 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: Baseline and 2-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Bulbar Conjunctival Redness | Baseline | 4.04 units on a scale | Standard Deviation 1.378 |
| Etafilcon A | Bulbar Conjunctival Redness | 2-week Follow-up | 4.13 units on a scale | Standard Deviation 1.17 |
| Prototype E1 | Bulbar Conjunctival Redness | 2-week Follow-up | 4.47 units on a scale | Standard Deviation 0.87 |
| Prototype E1 | Bulbar Conjunctival Redness | Baseline | 4.12 units on a scale | Standard Deviation 1.416 |
| Prototype E2 | Bulbar Conjunctival Redness | 2-week Follow-up | 4.18 units on a scale | Standard Deviation 1.166 |
| Prototype E2 | Bulbar Conjunctival Redness | Baseline | 4.08 units on a scale | Standard Deviation 1.099 |
| Prototype E3 | Bulbar Conjunctival Redness | 2-week Follow-up | 4.28 units on a scale | Standard Deviation 1.431 |
| Prototype E3 | Bulbar Conjunctival Redness | Baseline | 4.24 units on a scale | Standard Deviation 1.136 |
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.
Time frame: Baseline and 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Conjunctival Injection | Baseline | 0 Percentage of Eyes |
| Etafilcon A | Conjunctival Injection | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Conjunctival Injection | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Conjunctival Injection | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Conjunctival Injection | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Conjunctival Injection | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E3 | Conjunctival Injection | Baseline | 0 Percentage of Eyes |
| Prototype E3 | Conjunctival Injection | 4-week Follow-up | 0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Corneal Edema | Baseline | 0 Percentage of Eyes |
| Etafilcon A | Corneal Edema | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Corneal Edema | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Corneal Edema | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Corneal Edema | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Corneal Edema | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E3 | Corneal Edema | Baseline | 0 Percentage of Eyes |
| Prototype E3 | Corneal Edema | 4-week Follow-up | 0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Corneal Neovascularization | Baseline | 0 Percentage of Eyes |
| Etafilcon A | Corneal Neovascularization | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Corneal Neovascularization | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Corneal Neovascularization | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Corneal Neovascularization | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Corneal Neovascularization | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E3 | Corneal Neovascularization | Baseline | 0 Percentage of Eyes |
| Prototype E3 | Corneal Neovascularization | 4-week Follow-up | 0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Corneal Staining | Baseline | 0 Percentage of Eyes |
| Etafilcon A | Corneal Staining | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Corneal Staining | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Corneal Staining | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Corneal Staining | Baseline | 0 Percentage of Eyes |
| Prototype E2 | Corneal Staining | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E3 | Corneal Staining | Baseline | 0 Percentage of Eyes |
| Prototype E3 | Corneal Staining | 4-week Follow-up | 0 Percentage of Eyes |
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.
Time frame: Baseline and 4-Week Follow-up
Population: The analysis population consist of all subjects that completed all study visits without a major protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Corneal Staining (Area) | Baseline | 11.76 Units on a scale | Standard Deviation 24.676 |
| Etafilcon A | Corneal Staining (Area) | 4-week Follow-up | 5.29 Units on a scale | Standard Deviation 12.367 |
| Prototype E1 | Corneal Staining (Area) | 4-week Follow-up | 4.21 Units on a scale | Standard Deviation 9.482 |
| Prototype E1 | Corneal Staining (Area) | Baseline | 5.79 Units on a scale | Standard Deviation 18.4 |
| Prototype E2 | Corneal Staining (Area) | Baseline | 4.17 Units on a scale | Standard Deviation 6.918 |
| Prototype E2 | Corneal Staining (Area) | 4-week Follow-up | 8.06 Units on a scale | Standard Deviation 7.491 |
| Prototype E3 | Corneal Staining (Area) | Baseline | 6.18 Units on a scale | Standard Deviation 17.925 |
| Prototype E3 | Corneal Staining (Area) | 4-week Follow-up | 9.69 Units on a scale | Standard Deviation 8.224 |
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.
Time frame: Baseline and 4-Week Follow-up
Population: The analysis population consist of all subjects that completed all study visits without a major protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Corneal Staining (Depth) | Baseline | 1.03 Units on a scale | Standard Deviation 2.037 |
| Etafilcon A | Corneal Staining (Depth) | 4-week Follow-up | 0.53 Units on a scale | Standard Deviation 1.237 |
| Prototype E1 | Corneal Staining (Depth) | 4-week Follow-up | 0.42 Units on a scale | Standard Deviation 0.948 |
| Prototype E1 | Corneal Staining (Depth) | Baseline | 0.45 Units on a scale | Standard Deviation 1.224 |
| Prototype E2 | Corneal Staining (Depth) | Baseline | 0.36 Units on a scale | Standard Deviation 0.593 |
| Prototype E2 | Corneal Staining (Depth) | 4-week Follow-up | 0.81 Units on a scale | Standard Deviation 0.749 |
| Prototype E3 | Corneal Staining (Depth) | Baseline | 0.44 Units on a scale | Standard Deviation 1.045 |
| Prototype E3 | Corneal Staining (Depth) | 4-week Follow-up | 0.97 Units on a scale | Standard Deviation 0.822 |
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.
Time frame: Baseline and 4-Week Follow-up
Population: The analysis population consist of all subjects that completed all study visits without a major protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Corneal Staining (Type) | Baseline | 1.03 Units on a scale | Standard Deviation 2.037 |
| Etafilcon A | Corneal Staining (Type) | 4-week Follow-up | 0.53 Units on a scale | Standard Deviation 1.237 |
| Prototype E1 | Corneal Staining (Type) | 4-week Follow-up | 0.42 Units on a scale | Standard Deviation 0.948 |
| Prototype E1 | Corneal Staining (Type) | Baseline | 0.58 Units on a scale | Standard Deviation 1.84 |
| Prototype E2 | Corneal Staining (Type) | Baseline | 0.42 Units on a scale | Standard Deviation 0.692 |
| Prototype E2 | Corneal Staining (Type) | 4-week Follow-up | 0.81 Units on a scale | Standard Deviation 0.749 |
| Prototype E3 | Corneal Staining (Type) | Baseline | 0.59 Units on a scale | Standard Deviation 1.829 |
| Prototype E3 | Corneal Staining (Type) | 4-week Follow-up | 0.94 Units on a scale | Standard Deviation 0.801 |
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.
Time frame: Post Lens Fitting and 4-Week Follow-up
Population: The analysis population consists of all subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Lens Fitting Characteristics | Post Lens Fitting | 100 Percentage of Eyes |
| Etafilcon A | Lens Fitting Characteristics | 4-week Follow-up | 100 Percentage of Eyes |
| Prototype E1 | Lens Fitting Characteristics | 4-week Follow-up | 100 Percentage of Eyes |
| Prototype E1 | Lens Fitting Characteristics | Post Lens Fitting | 100 Percentage of Eyes |
| Prototype E2 | Lens Fitting Characteristics | 4-week Follow-up | 100 Percentage of Eyes |
| Prototype E2 | Lens Fitting Characteristics | Post Lens Fitting | 100 Percentage of Eyes |
| Prototype E3 | Lens Fitting Characteristics | Post Lens Fitting | 100 Percentage of Eyes |
| Prototype E3 | Lens Fitting Characteristics | 4-week Follow-up | 100 Percentage of 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.
Time frame: Baseline and 2-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Limbal Conjunctival Redness | Baseline | 4.0 units on a scale | Standard Deviation 1.822 |
| Etafilcon A | Limbal Conjunctival Redness | 2-week Follow-up | 3.93 units on a scale | Standard Deviation 1.441 |
| Prototype E1 | Limbal Conjunctival Redness | 2-week Follow-up | 3.54 units on a scale | Standard Deviation 1.472 |
| Prototype E1 | Limbal Conjunctival Redness | Baseline | 3.50 units on a scale | Standard Deviation 1.564 |
| Prototype E2 | Limbal Conjunctival Redness | Baseline | 3.72 units on a scale | Standard Deviation 1.485 |
| Prototype E2 | Limbal Conjunctival Redness | 2-week Follow-up | 3.72 units on a scale | Standard Deviation 1.446 |
| Prototype E3 | Limbal Conjunctival Redness | Baseline | 4.06 units on a scale | Standard Deviation 1.294 |
| Prototype E3 | Limbal Conjunctival Redness | 2-week Follow-up | 3.53 units on a scale | Standard Deviation 1.646 |
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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Burning/Stinging) | Baseline | 5.9 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Burning/Stinging) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Burning/Stinging) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Burning/Stinging) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Burning/Stinging) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Burning/Stinging) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Burning/Stinging) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Burning/Stinging) | 4- Week Follow-up | 6.3 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | Baseline | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | Baseline | 5.3 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy) | Baseline | 0.0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Dryness) | Baseline | 5.9 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Dryness) | 4- Week Follow-up | 5.9 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Dryness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Dryness) | Baseline | 15.8 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Dryness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Dryness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Dryness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Dryness) | 4- Week Follow-up | 0.0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | Baseline | 0.0 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | Baseline | 5.3 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation) | 4- Week Follow-up | 0.0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | Baseline | 0.0 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | 4- Week Follow-up | 5.9 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | Baseline | 5.3 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Irritation/Discomfort) | 4- Week Follow-up | 0.0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | Baseline | 0.0 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness) | 4- Week Follow-up | 0.0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Lens Awareness) | Baseline | 0.0 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Lens Awareness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Lens Awareness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Lens Awareness) | Baseline | 10.5 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Lens Awareness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Lens Awareness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Lens Awareness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Lens Awareness) | 4- Week Follow-up | 0.0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Redness) | Baseline | 0.0 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Redness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Redness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Redness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Redness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Redness) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Redness) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Redness) | 4- Week Follow-up | 0.0 Percentage of 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.
Time frame: Baseline and 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Percentage of Reported Ocular Symptoms (Variable Vision) | Baseline | 0.0 Percentage of Eyes |
| Etafilcon A | Percentage of Reported Ocular Symptoms (Variable Vision) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Variable Vision) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E1 | Percentage of Reported Ocular Symptoms (Variable Vision) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Variable Vision) | Baseline | 0.0 Percentage of Eyes |
| Prototype E2 | Percentage of Reported Ocular Symptoms (Variable Vision) | 4- Week Follow-up | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Variable Vision) | Baseline | 0.0 Percentage of Eyes |
| Prototype E3 | Percentage of Reported Ocular Symptoms (Variable Vision) | 4- Week Follow-up | 0.0 Percentage of 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.
Time frame: 1-, 2- and 4-Week Follow-up
Population: The analysis population consists of all subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A | Tarsal Abnormalities | 1-week Follow-up | 0 Percentage of Eyes |
| Etafilcon A | Tarsal Abnormalities | 4-week Follow-up | 0 Percentage of Eyes |
| Etafilcon A | Tarsal Abnormalities | 2-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Tarsal Abnormalities | 1-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Tarsal Abnormalities | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E1 | Tarsal Abnormalities | 2-week Follow-up | 0 Percentage of Eyes |
| Prototype E2 | Tarsal Abnormalities | 1-week Follow-up | 0 Percentage of Eyes |
| Prototype E2 | Tarsal Abnormalities | 2-week Follow-up | 0 Percentage of Eyes |
| Prototype E2 | Tarsal Abnormalities | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E3 | Tarsal Abnormalities | 1-week Follow-up | 0 Percentage of Eyes |
| Prototype E3 | Tarsal Abnormalities | 4-week Follow-up | 0 Percentage of Eyes |
| Prototype E3 | Tarsal Abnormalities | 2-week Follow-up | 0 Percentage of Eyes |
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.
Time frame: 4-Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Visual Acuity (LogMAR) | -0.15 LogMAR | Standard Deviation 0.078 |
| Prototype E1 | Visual Acuity (LogMAR) | -0.12 LogMAR | Standard Deviation 0.067 |
| Prototype E2 | Visual Acuity (LogMAR) | -0.13 LogMAR | Standard Deviation 0.076 |
| Prototype E3 | Visual Acuity (LogMAR) | -0.13 LogMAR | Standard Deviation 0.086 |