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The purpose of this study is to determine the benefits of fitting low astigmats with soft toric contact lenses versus spherical contact lenses with regard to visual comfort, eyestrain, fitting efficiency, and visual performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A/etafilcon A for Astigmatism | Active Comparator | Subjects were randomized to one of two sequences of lens wear. |
|
| etafilcon A for Astigmatism/etafilcon A | Experimental | Subjects were randomized to one of two sequences of lens wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Soft contact lens to be worn in a daily wear, daily disposable modality for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Comfort Assessed by Electromyography(EMG) | Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose. | 1 week |
| Visual Comfort | The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0. The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life. This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction. An overall score is calculated by averaging the subscales. The overall scores can take on values of 0 to 100. Higher scores indicate better outcomes | 1-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston | Texas | 77204 | United States |
Of those completed 24 were excluded from the analysis due to a major protocol deviation. Of the subjects that completed all study visits without a major protocol deviation, 10 subjects were classified as neophytes and 60 as habitual contact lens users.
A total of 159 subjects were enrolled in the study. Of the enrolled subjects 45 did not meet the eligibility criteria and 114 subjects were dispensed a study lens. Of the dispensed subjects 10 subjects were discontinued and 94 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/ Etafilcon A for Astigmatism | Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens. |
| FG001 | Etafilcon A for Astigmatism/Etafilcon A | Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||||||||
| Period 2 |
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Analysis population consists of 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 study lens. |
| 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 | Objective Comfort Assessed by Electromyography(EMG) | Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose. | Analysis population consists of all subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | volts | 1 week |
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 | Etafilcon A | Subjects that received the etafilcon A lens in either the first or second period of the study. |
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Data collected on Neophyte population was for exploratory purpose only. The study was not powered to show differences in this population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathrine E. Osborn, OD, MS, FAAO- DIRECTOR GLOBAL STRATEGIC CLAIMS | Johnson and Johnson Vision Care Inc. | 904-443-1032 | KOSBORN@its.jnj.com |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A for Astigmatism | Device | Soft contact lens to be worn by participants in a daily wear, daily disposable modality for one week. |
|
| Unsatisfactory Lens Fit |
|
| Unsatisfactory Visual Response |
|
| Physician Decision |
|
| Neophytes |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | All subjects that were dispensed a study lens. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Etafilcon A | Subjects that received the etafilcon A lens in either the first or second period of the study. |
| OG001 | Etafilcon A for Astigmatism | Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study. |
|
|
| Primary | Visual Comfort | The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0. The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life. This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction. An overall score is calculated by averaging the subscales. The overall scores can take on values of 0 to 100. Higher scores indicate better outcomes | The analysis population consists of all subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 1-week follow-up |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | Etafilcon A for Astigmatism | Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study. | 0 | 114 | 0 | 114 |
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