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This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A / lotrafilcon B | Active Comparator | Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens and then wore the lotrafilcon B contact lens. |
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| lotrafilon B/ senofilcon A | Active Comparator | Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the lotrafilcon B contact lens and then wore the senofilcon A contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A | Device | Each study contact lens will be worn as daily wear modality for a period of 2 weeks each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Kinetics | The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses. | 8 hour post insertion |
| Time Controlled Visual Acuity | The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17" LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3" LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units. | 8 hours post insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | SW1E 6AU | United Kingdom |
A total of 45 subjects were enrolled into this study. Of the enrolled subjects 43 were dispensed and 2 subjects did not meet the eligibility criteria. Of the 43 dispensed subjects, 1 subject was discontinued 42 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/ Lotrafilcon B | Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period. |
| FG001 | Lotrafilcon B / Senofilcon A | Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All subjects that were dispensed at least one study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least one lens throughout the duration of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tear Film Kinetics | The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses. | The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation. | Posted | Mean | Standard Deviation | Seconds | 8 hour post insertion |
|
Throughout the duration of the study. Approximately 1 month per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Senofilcon A | Subjects that received the senofilcon A contact lens in either the first or second period of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | General disorders | Non-ocular adverse event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tawnya Wilson OD | Johnson & Johnson Vision Care Inc. | 904-443-3500 | 1834 | TWilson@ITS.JNJ.com |
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| ID | Term |
|---|---|
| D014985 | Xerophthalmia |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
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| lotrafilcon B | Device | Each study contact lens will be worn as daily wear modality for a period of 2 weeks each. |
|
| NOT COMPLETED |
|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lotrafilcon B |
Subjects that received the lotrafilcon B in either the first or second period of the study. |
|
|
| Primary | Time Controlled Visual Acuity | The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17" LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3" LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units. | The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m). | Posted | Mean | Standard Deviation | LogMAR | 8 hours post insertion |
|
|
|
| 0 |
| 43 |
| 3 |
| 43 |
| EG001 | Lotrafilcon B | Subjects that received the lotrafilcon B contact lens in either the first or second period of the study. | 0 | 43 | 4 | 43 |
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