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Limbal ring contact lenses enhance the look of the eye by adding pigmentation in a ring pattern to the contact lens. The purpose of this investigation is to determine if corneal staining increase is dependent upon the lens pigment location.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A/2-HEMA, EGDMA/hefilcon A | Other | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
| etafilcon A/hefilcon A/2-HEMA, EGDMA Non-ionic | Other | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
| 2-HEMA, EGDMA Non-ionic/etafilcon A/hefilcon A | Other | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
| 2-HEMA, EGDMA Non-ionic/hefilcon A/etafilcon A | Other | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A | Device | Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. 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 total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining. | 20 minutes and 7 hours post lens fitting |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Polytechnic University | Hong Hom | Kowloon | Hong Kong |
Of the remaining 34 subjects, 1 subjects withdrew consent before randomization and was discontinued from the study. A total of 33 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued and 31 completed the study. A total of 3 subjects were discontinued from this study.
A total of 35 subjects were enrolled in this study. Of the enrolled 1 subject did not meet the eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A/2-HEMA, EGDMA/Hefilcon A | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
| FG001 | Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
| FG002 | 2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
| FG003 | 2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
| FG004 | Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
| FG005 | Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
| FG006 | Not Assigned | Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All subjects enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All subjects that were enrolled into 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 | Corneal Staining | Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. 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 total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining. | All subjects that completed every study visit without a major protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | 20 minutes and 7 hours post lens fitting | Subject Eyes | Subject Eyes |
|
Throughout the duration of the study- approximately 3 days.
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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 any of the three study periods. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charis Lau, PharmD, OD, FAAO- Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-433-3500 | charislau@gmail.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| hefilcon A/2-HEMA, EGDMA Non-ionic/etafilcon A | Other | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
| hefilcon A/etafilcon A /2-HEMA, EGDMA Non-ionic | Other | Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
|
| 2-HEMA, EGDMA Non-ionic | Device | Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
|
| hefilcon A | Device | Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. |
|
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| Withdrawal by Subject |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | Participants |
|
| Etafilcon A |
Subjects that received the etafilcon A lens in any of the three study periods. |
| OG001 | 2-HEMA, EGDMA Non-ionic | Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods. |
| OG002 | Hefilcon A | Subjects that received the hefilcon A lens in any of the three study periods. |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 2-HEMA, EGDMA Non-ionic | Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods. | 0 | 34 | 0 | 34 |
| EG002 | Hefilcon A | Subjects that received the hefilcon A lens in any of the three study periods. | 0 | 34 | 0 | 34 |
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