| Primary | Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire | CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | | Mean | Standard Deviation | units on a scale | | 8 -12 days post wear | | | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B contact lens during either the first or second period of the study. |
| | | Title | Denominators | Categories |
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| Hyperopes, N=94, N=94 | | | Title | Measurements |
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| - OG00051.15± 21.647
- OG00154.28± 20.749
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| | Myopes, N=181, N=181 | | |
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| Primary | Distance Binocular Visual Acuity (LogMAR) | Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast. | The analysis population consists of subjects that have completed all study visits without a major protocol deviation. | Posted | | Mean | Standard Deviation | LogMAR | | 8- 12 Days post wear | | | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B during either the first or second period of the study. |
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| Primary | Intermediate Binocular Visual Acuity (LogMAR) | Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | | Mean | Standard Deviation | LogMAR | | 8-12 days post wear | | | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B contact lens during either the first or second period of the study. |
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| Primary | Near Binocular Visual Acuity (LogMAR) | Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. | Posted | | Mean | Standard Deviation | LogMAR | | 8-12 days post wear | | | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B contact lens during either the first or second period of the study. |
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| Primary | Corneal Staining | Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | | Number | | percentage of Subject Eyes | | 8 - 12 Days post wear | Subject Eyes | Subject Eyes | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B contact lens during either the first or second period of the study. |
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| Primary | Bulbar Conjunctival Injection | The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | | Number | | Percentage of Subject Eyes | | 8- 12 Days post wear | Subject Eyes | Subject Eyes | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B contact lens during either the first or second period of the study. |
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| Primary | Limbal Conjunctival Injection | The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | | Number | | Percentage of Subject Eyes | | 8- 12 Days post wear | Subject Eyes | Subject Eyes | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B contact lens during either the first or second period of the study. |
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| Primary | Contact Lens Fitting | Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes. | Posted | | Number | | Percentage of Subject Eyes | | 8- 12 Days post wear | Subject Eyes | Subject Eyes | | ID | Title | Description |
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| OG000 | Etafilcon A | Subjects that received the etafilcon A contact lens during either the first or second period of the study. | | OG001 | Lotrafilcon B | Subjects that received the lotrafilcon B during either the first or second period of the study. |
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